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Innolitics
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Review Panel
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Review Panel
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Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
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Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
EAG
Cephalometer
2
Product Code
EAH
Cone, Radiographic, Lead-Lined
1
Product Code
EAP
Unit, X-Ray, Intraoral
2
Product Code
EHB
Collimator, X-Ray
1
Product Code
EHD
Unit, X-Ray, Extraoral With Timer
2
Product Code
MUH
System, X-Ray, Extraoral Source, Digital
2
Product Code
EAM
Screen, Intensifying, Radiographic
1
Product Code
EGT
Controller, Temperature, Radiographic
2
Product Code
EGW
Dryer, Film, Radiographic
2
Product Code
EGY
Processor, Radiographic-Film, Automatic, Dental
2
Product Code
HBK
Chair, Pneumoencephalographic
2
Product Code
ITX
Transducer, Ultrasonic, Diagnostic
2
Product Code
ITY
Assembly, Tube Housing, X-Ray, Diagnostic
1
Product Code
IWN
Cassette, Measurement, Ardran-Crooks
1
Product Code
IWY
Holder, Head, Radiographic
1
Product Code
IWZ
Film, Radiographic
1
Product Code
IXA
Cassette, Radiographic Film
2
Product Code
IXC
Illuminator, Radiographic-Film
1
Product Code
IXD
Source, Calibration, Sealed, Nuclear
1
Product Code
IXF
Test-Pattern, Radiographic
1
Product Code
IXG
Phantom, Anthropomorphic, Radiographic
1
Product Code
IXH
Camera, Focal Spot, Radiographic
1
Product Code
IXJ
Grid, Radiographic
1
Product Code
IXK
System, Imaging, X-Ray, Electrostatic
2
Product Code
IXL
Device, Spot-Film
2
Product Code
IXO
Synchronizer, Ecg / Respirator, Radiographic
1
Product Code
IXQ
Table, Radiographic, Stationary Top
2
Product Code
IXR
Table, Radiographic, Tilting
2
Product Code
IXW
Processor, Radiographic-Film, Automatic
2
Product Code
IXX
Processor, Cine Film
2
Product Code
IXY
Holder, Radiographic Cassette, Wall-Mounted
1
Product Code
IYB
Tube Mount, X-Ray, Diagnostic
1
Product Code
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
2
Product Code
IYO
System, Imaging, Pulsed Echo, Ultrasonic
2
Product Code
IYP
Phantom, Anthropomorphic, Nuclear
1
Product Code
IYQ
Phantom, Flood Source, Nuclear
1
Product Code
IYT
System, Rebreathing, Radionuclide
2
Product Code
IYW
Scanner, Rectilinear, Nuclear
1
Product Code
IYX
Camera, Scintillation (Gamma)
1
Product Code
IYY
Synchronizer, Electrocardiograph, Nuclear
1
Product Code
IYZ
Bed, Scanning, Nuclear
1
Product Code
IZC
Camera, Positron
1
Product Code
IZD
Probe, Uptake, Nuclear
1
Product Code
IZF
System, X-Ray, Tomographic
2
Product Code
IZG
System, X-Ray, Photofluorographic
2
Product Code
IZH
System, X-Ray, Mammographic
2
Product Code
IZI
System, X-Ray, Angiographic
2
Product Code
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
2
Product Code
IZL
System, X-Ray, Mobile
2
Product Code
IZO
Generator, High-Voltage, X-Ray, Diagnostic
1
Product Code
IZP
Programmer, Changer, Film/Cassette, Radiographic
2
Product Code
IZS
Aperture, Radiographic
2
Product Code
IZT
Cone, Radiographic
2
Product Code
IZW
Collimator, Automatic, Radiographic
2
Product Code
IZX
Collimator, Manual, Radiographic
2
Product Code
IZZ
Table, Radiographic, Non-Tilting, Powered
2
Product Code
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
2
Product Code
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
2
Product Code
JAC
System, X-Ray, Film Marking, Radiographic
1
Product Code
JAF
Monitor, Ultrasonic, Nonfetal
2
Product Code
JAG
Illuminator, Radiographic-Film, Explosion-Proof
1
Product Code
JAK
System, X-Ray, Tomography, Computed
2
Product Code
JAM
Scanner, Whole Body, Nuclear
1
Product Code
JAN
Counter, Whole Body, Nuclear
1
Product Code
JAO
Scanner, Fluorescent
2
Product Code
JAR
Phantom, Test-Pattern, Radionuclide
1
Product Code
JWM
System, Tomographic, Nuclear
2
Product Code
KGI
Densitometer, Bone
2
Product Code
KPR
System, X-Ray, Stationary
2
Product Code
KPS
System, Tomography, Computed, Emission
2
Product Code
KPT
Calibrator, Dose, Radionuclide
2
Product Code
KPW
Device, Beam Limiting, X-Ray, Diagnostic
2
Product Code
KPX
Changer, Radiographic Film/Cassette
2
Product Code
KXH
Cradle, Patient, Radiologic
1
Product Code
KXJ
Table, Radiologic
2
Product Code
LEK
Transilluminator (Diaphanoscope)
3
Product Code
LHO
Instrument, Quality-Assurance, Radiologic
1
Product Code
LLZ
System, Image Processing, Radiological
2
Product Code
LMA
Digitizer, Image, Radiological
2
Product Code
LMB
Device, Digital Image Storage, Radiological
1
Product Code
LMC
Camera, Multi Format, Radiological
2
Product Code
LMD
System, Digital Image Communications, Radiological
1
Product Code
LNH
System, Nuclear Magnetic Resonance Imaging
2
Product Code
K
24
1242
SIGNA MAGNUS
2
Cleared 510(K)
K
24
1925
VitruvianScan (v1.0)
2
Cleared 510(K)
K
24
1331
MuscleView
2
Cleared 510(K)
K
24
1607
MyoStrain (6.0)
2
Cleared 510(K)
K
24
1496
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
24
1429
ECHELON Synergy MRI System
2
Cleared 510(K)
K
23
1133
neo315
2
Cleared 510(K)
K
24
0944
Swoop® Portable MR Imaging® System
2
Cleared 510(K)
K
24
1133
Magnifico Open (100009900); Magnifico MSK ( 100009910)
2
Cleared 510(K)
K
23
3629
APERTO Lucent MRI System
2
Cleared 510(K)
K
23
3687
ECHELON Synergy V10.0
2
Cleared 510(K)
K
23
3673
uMR Jupiter
2
Cleared 510(K)
K
24
0571
OASIS MRI System
2
Cleared 510(K)
K
24
0238
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
24
0744
uMR 680
2
Cleared 510(K)
K
24
0608
MAGNETOM Viato.Mobile
2
Cleared 510(K)
K
23
3733
SyMRI
2
Cleared 510(K)
K
24
0540
uMR Omega
2
Cleared 510(K)
K
23
2322
MAGNETOM Terra; MAGNETOM Terra.X
2
Cleared 510(K)
K
23
2765
MAGNETOM Cima.X Fit
2
Cleared 510(K)
K
24
0157
InVision™ 1.5 Surgical Theatre
2
Cleared 510(K)
K
23
2644
neuro42 MRI System
2
Cleared 510(K)
K
23
3728
SIGNA Champion
2
Cleared 510(K)
K
23
2535
MAGNETOM Sola; MAGNETOM Altea
2
Cleared 510(K)
K
23
1587
MAGNETOM Cima.X
2
Cleared 510(K)
K
23
2680
fMRI Hardware System
2
Cleared 510(K)
K
23
2494
MAGNETOM Avanto fit; MAGNETOM Skyra fit
2
Cleared 510(K)
K
23
1617
MAGNETOM Free.Max; MAGNETOM Free.Star
2
Cleared 510(K)
K
23
2346
Digital Expert Access with Remote Scanning
2
Cleared 510(K)
K
23
1560
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
2
Cleared 510(K)
K
23
2981
Synq Software Version 1.3
2
Cleared 510(K)
K
23
2760
Swoop® Portable MR Imaging System®
2
Cleared 510(K)
K
23
0187
Terran NM-101
2
Cleared 510(K)
K
23
2482
MAGNETOM Viato.Mobile
2
Cleared 510(K)
K
23
2361
Promaxo MRI System II
2
Cleared 510(K)
K
23
0355
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
23
2030
Ingenia Elition R5.7.1 SP4 MR Systems
2
Cleared 510(K)
K
22
3426
ECHELON Synergy MRI system
2
Cleared 510(K)
K
23
1459
HepaFatSmart (V2.0.0)
2
Cleared 510(K)
K
22
3523
Sonic DL
2
Cleared 510(K)
K
23
0152
uMR Omega
2
Cleared 510(K)
K
23
0758
uMR 570
2
Cleared 510(K)
K
23
0972
Ingenia Elition and MR 7700 MR Systems
2
Cleared 510(K)
K
22
3458
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
2
Cleared 510(K)
K
22
3343
MAGNETOM Amira; MAGNETOM Sempra
2
Cleared 510(K)
K
22
3875
MOBINEURO Alita Intraoperative MRI System
2
Cleared 510(K)
K
22
3203
1.5T 24E Posterior Array
2
Cleared 510(K)
K
21
3805
MAGNETOM Vida
2
Cleared 510(K)
K
23
0208
Swoop® Portable MR Imaging System™
2
Cleared 510(K)
K
22
2259
NEONA 1.5T MRI System
2
Cleared 510(K)
K
22
2755
uMR 680
2
Cleared 510(K)
K
22
3439
SIGNA Victor
2
Cleared 510(K)
K
22
1619
ECHELON Oval V6.2 MRI System
2
Cleared 510(K)
K
22
3442
MR 5300 and MR 7700 R11 MR Systems
2
Cleared 510(K)
K
22
3247
Swoop Portable MR Imaging System
2
Cleared 510(K)
K
22
3079
Stage
2
Cleared 510(K)
K
22
0332
uMR Omega with uWS-MR-MRS
2
Cleared 510(K)
K
22
2968
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
22
1733
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
2
Cleared 510(K)
K
21
3960
LiverMultiScan v5 (LMSv5)
2
Cleared 510(K)
K
22
2387
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
22
1785
TCL3 Motion Tracking System
2
Cleared 510(K)
K
22
1923
Swoop Portable MR Imaging System
2
Cleared 510(K)
K
20
3279
Veuron-Brain-mN1
2
Cleared 510(K)
K
22
1025
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
2
Cleared 510(K)
K
22
0575
MAGNETOM Free.Max, MAGNETOM Free.Star
2
Cleared 510(K)
K
22
1393
Swoop Portable MR Imaging System
2
Cleared 510(K)
K
21
3717
AIR Recon DL
2
Cleared 510(K)
K
21
3583
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
2
Cleared 510(K)
K
22
0589
MAGNETOM Skyra Fit
2
Cleared 510(K)
K
22
0939
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
2
Cleared 510(K)
K
22
0192
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
22
0335
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
22
0151
MAGNETOM Avanto Fit
2
Cleared 510(K)
K
22
0425
MAGNETOM Vida, MAGNETOM Sola
2
Cleared 510(K)
K
22
0018
MR Elastography; MZEK-001A
2
Cleared 510(K)
K
21
3516
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
2
Cleared 510(K)
K
21
3693
MAGNETOM Vida with syngo MR XA50A
2
Cleared 510(K)
K
21
3603
SIGNA Artist Evo
2
Cleared 510(K)
K
21
2419
Magnifico Open, Magnifico MSK
2
Cleared 510(K)
K
21
2271
smart-sync
2
Cleared 510(K)
K
21
3668
SIGNA Hero
2
Cleared 510(K)
K
21
1980
SIGNA Prime
2
Cleared 510(K)
K
21
3305
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
21
1983
AMRA Profiler
2
Cleared 510(K)
K
21
2673
MR 5300
2
Cleared 510(K)
K
21
2456
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
2
Cleared 510(K)
K
20
3372
SyMRI
2
Cleared 510(K)
K
21
1406
OASIS MRI System
2
Cleared 510(K)
K
21
2233
RTHawk, HeartVista Cardiac Package
2
Cleared 510(K)
K
21
2367
IMRIS iMRI 3T V
2
Cleared 510(K)
K
21
2056
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
21
1633
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
21
0415
QSM software, QSMetric
2
Cleared 510(K)
K
21
1818
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
2
Cleared 510(K)
K
21
0611
MAGNETOM Free.Max
2
Cleared 510(K)
K
21
0843
STAGE
2
Cleared 510(K)
K
21
1037
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
21
1118
SIGNA 7.0T
2
Cleared 510(K)
K
20
3451
TCL3 Motion Tracking System
2
Cleared 510(K)
K
21
0340
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
20
3443
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
2
Cleared 510(K)
K
21
0164
Vantage Elan 1.5T, MRT-2020, V6.0
2
Cleared 510(K)
K
20
3323
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
20
2518
Promaxo MRI System
2
Cleared 510(K)
K
20
3653
MRI PPG Patient Cable
2
Cleared 510(K)
K
20
3553
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
19
2650
i_Space 1.5T Superconducting Magnetic Resonance Imaging System
2
Cleared 510(K)
K
20
2767
Vantage Orian 1.5T, MRT-1550, V6.0
2
Cleared 510(K)
K
20
3280
Hepatica v1 (Hepatica v1.0.0)
2
Cleared 510(K)
K
20
1039
HepaFat-AI
2
Cleared 510(K)
K
20
3053
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
20
2966
SIGNA Architect
2
Cleared 510(K)
K
20
2030
OASIS MRI System
2
Cleared 510(K)
K
20
1615
SIGNA 7.0T
2
Cleared 510(K)
K
20
2170
LiverMultiScan
2
Cleared 510(K)
K
20
2210
Vantage Orian 1.5T, MRT-1550, V6.0
2
Cleared 510(K)
K
20
2014
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
2
Cleared 510(K)
K
20
2238
SIGNA Artist
2
Cleared 510(K)
K
20
1141
FIRMM
2
Cleared 510(K)
K
20
1722
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
2
Cleared 510(K)
K
20
1616
SyMRI
2
Cleared 510(K)
K
19
3097
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
20
1389
Resoundant Acoustic Driver System
2
Cleared 510(K)
K
20
1540
uMR570
2
Cleared 510(K)
K
19
3021
Vantage Orian 1.5T, MRT-1550, V6.0
2
Cleared 510(K)
K
19
3176
uMR 780
2
Cleared 510(K)
K
20
0327
Evry
2
Cleared 510(K)
K
20
0024
uMR 570
2
Cleared 510(K)
K
19
3282
SIGNA Premier
2
Cleared 510(K)
K
19
3215
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
2
Cleared 510(K)
K
19
3218
Innovision Audio
2
Cleared 510(K)
K
19
2852
MRI ECG Patient Cable
2
Cleared 510(K)
K
19
3200
uMR Omega
2
Cleared 510(K)
K
19
2924
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
2
Cleared 510(K)
K
19
2574
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
2
Cleared 510(K)
K
19
2506
Vantage Galan 3T, MRT-3020, V6.0
2
Cleared 510(K)
K
19
2496
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
2
Cleared 510(K)
K
19
2851
OASIS MRI System
2
Cleared 510(K)
K
19
2002
Lucy Point-of-Care Magnetic Resonance Imaging Device
2
Cleared 510(K)
K
19
3324
Motion Correction System
2
Cleared 510(K)
K
19
3102
MRIaudio PREM System with MRIview
2
Cleared 510(K)
K
19
3116
MRopen EVO
2
Cleared 510(K)
K
19
1032
fMRI Hardware System
2
Cleared 510(K)
K
19
2690
Upgrade Kit MR GUI PRO, MrJ 3300 Plus
2
Cleared 510(K)
K
18
3274
RTHawk, HeartVista Cardiac Package
2
Cleared 510(K)
K
19
2426
Signa Voyager, Signa Voyager Quantum
2
Cleared 510(K)
K
19
1662
Vantage Orian 1.5T, MRT-1550, V4.5
2
Cleared 510(K)
K
19
1050
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow
2
Cleared 510(K)
K
19
0524
MRopen 0.5 T
2
Cleared 510(K)
K
19
0017
LiverMultiScan (LMSv3)
2
Cleared 510(K)
K
19
1128
Vantage Titan 3T, MRT-3010, V2.5
2
Cleared 510(K)
K
19
1036
SyMRI
2
Cleared 510(K)
K
19
0461
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
2
Cleared 510(K)
K
19
0757
MAGNETOM Avanto Fit
2
Cleared 510(K)
K
19
1157
uMR 780, uMR 790
2
Cleared 510(K)
K
18
3657
Vantage Galan 3T, MRT-3020/A9, V5.0
2
Cleared 510(K)
K
18
3621
EMMA 1.5T MRI System
2
Cleared 510(K)
K
19
0138
MAGNETOM Aera
2
Cleared 510(K)
K
18
3222
MAGNETOM Terra
2
Cleared 510(K)
K
18
3221
MAGNETOM Amira, MAGNETOM Sempra
2
Cleared 510(K)
K
18
3063
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
2
Cleared 510(K)
K
18
2756
MyoStrain 5.1
2
Cleared 510(K)
K
18
3244
MAGNETOM Lumina
2
Cleared 510(K)
K
18
3685
O-Scan
2
Cleared 510(K)
K
18
3254
Magnetom Vida
2
Cleared 510(K)
K
18
3231
SIGNA Premier
2
Cleared 510(K)
K
18
3137
uMR 580, uMR 588
2
Cleared 510(K)
K
17
3749
AMRA Profiler
2
Cleared 510(K)
K
18
1613
MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
2
Cleared 510(K)
K
18
2299
MAGNETOM Aera
2
Cleared 510(K)
K
18
2282
Vantage Orian 1.5T, MRT-1550, V4.5
2
Cleared 510(K)
K
18
1433
MAGNETOM Vida
2
Cleared 510(K)
K
18
2129
MAGNETOM Sola
2
Cleared 510(K)
K
18
1322
MAGNETOM Sola
2
Cleared 510(K)
K
18
1370
uMR 780
2
Cleared 510(K)
K
18
1371
uMR 790
2
Cleared 510(K)
K
18
1593
Vantage Galan 3T, MRT-3020/A7, V5.0
2
Cleared 510(K)
K
18
1479
Ingenia Ambition S and Ingenia Ambition X
2
Cleared 510(K)
K
17
3507
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
2
Cleared 510(K)
K
18
0100
MRIaudio PREM System
2
Cleared 510(K)
K
18
1093
SyMRI
2
Cleared 510(K)
K
18
0926
uMR 560
2
Cleared 510(K)
K
18
0925
uMR 570
2
Cleared 510(K)
K
17
3079
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
2
Cleared 510(K)
K
18
0592
G-scan Brio
2
Cleared 510(K)
K
17
3617
MAGNETOM Vida with Compressed Sensing GRASP-VIBE
2
Cleared 510(K)
K
17
3451
Ingenia Elition S and Ingenia Elition X
2
Cleared 510(K)
K
17
1778
MR Wireless Gating System, Model WGS-100
2
Cleared 510(K)
K
17
3356
Ingenia Elition S and Ingenia Elition X R5.4
2
Cleared 510(K)
K
17
3224
SPIN-SWI
2
Cleared 510(K)
K
17
3409
Wireless Audio System
2
Cleared 510(K)
K
17
3592
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
2
Cleared 510(K)
K
17
3558
SyMRI
2
Cleared 510(K)
K
17
3382
Vantage Galan 3T, V4.6
2
Cleared 510(K)
K
17
2920
3D APT
2
Cleared 510(K)
K
17
2110
ECHELON OVAL V6.0A MRI System
2
Cleared 510(K)
K
17
3600
MAGNETOM Amira
2
Cleared 510(K)
K
17
2685
LiverMultiScan
2
Cleared 510(K)
K
17
2878
Vantage Titan 3T, MRT-3010/A7, M-Power GX
2
Cleared 510(K)
K
17
0840
MAGNETOM Terra
2
Cleared 510(K)
K
16
2943
SyMRI
2
Cleared 510(K)
K
17
1597
Vantage Elan 1.5T, V4.0
2
Cleared 510(K)
K
17
0978
Embrace Neonatal MRI System
2
Cleared 510(K)
K
17
1128
SIGNA Premier
2
Cleared 510(K)
K
17
0090
RTHawk, HeartVista Cardiac Package
2
Cleared 510(K)
K
17
0396
MAGNETOM Vida
2
Cleared 510(K)
K
17
0412
Vantage Titan 1.5T, MRT-1510, M-Power GX
2
Cleared 510(K)
K
16
2722
HyperSense
2
Cleared 510(K)
K
16
3192
Comfort EC710
2
Cleared 510(K)
K
16
3331
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist
2
Cleared 510(K)
K
16
3312
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
2
Cleared 510(K)
K
16
3211
MAGNETOM Sempra with syngo MR E11S
2
Cleared 510(K)
K
16
3116
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
2
Cleared 510(K)
K
16
2931
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
2
Cleared 510(K)
K
16
2940
MultiBand SENSE
2
Cleared 510(K)
K
16
2183
Vantage Galan 3T, MRT-3020, V4.0
2
Cleared 510(K)
K
16
2102
MAGNETOM Avantofit, MAGNETOM Skyrafit
2
Cleared 510(K)
K
16
2403
HyperBand
2
Cleared 510(K)
K
16
1795
MAGNETOM ESSENZA
2
Cleared 510(K)
K
16
1973
G-scan Brio, S-scan
2
Cleared 510(K)
K
16
1567
SIGNA Voyager
2
Cleared 510(K)
K
16
1397
MAGiC
2
Cleared 510(K)
K
16
0632
Vantage Titan 1.5T, MRT-1510, V3.6 Software
2
Cleared 510(K)
K
16
1238
S-scan
2
Cleared 510(K)
K
15
3740
RTHawk, HeartVista Cardiac Package
2
Cleared 510(K)
K
16
0618
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
2
Cleared 510(K)
K
16
0152
Trillium Oval V 5.1 MRI System
2
Cleared 510(K)
K
15
3343
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
2
Cleared 510(K)
K
15
3547
ECHELON Oval V 5.1 MRI System
2
Cleared 510(K)
K
15
3447
MAGNETOM Spectra
2
Cleared 510(K)
K
16
0621
SIGNAPioneer
2
Cleared 510(K)
K
15
3324
Ingenia 1.5T and Ingenia 1.5T S R5.2
2
Cleared 510(K)
K
16
0185
Wrist 3
2
Cleared 510(K)
K
15
3039
MRI Dynamic Analysis Plus
2
Cleared 510(K)
K
15
2283
MAGNETOM Amira
2
Cleared 510(K)
K
15
1074
Magnetic Reasonance Imaging System
2
Cleared 510(K)
K
15
3003
SIGNA Pioneer
2
Cleared 510(K)
K
15
2371
Vantage Titan 3T
2
Cleared 510(K)
K
15
1466
MrOpen
2
Cleared 510(K)
K
15
1579
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
2
Cleared 510(K)
K
15
1668
S-scan
2
Cleared 510(K)
K
15
1015
ECHELON Oval V 5.0 MRI System
2
Cleared 510(K)
K
14
3345
SIGNA Pioneer
2
Cleared 510(K)
K
14
3020
LiverMultiScan
2
Cleared 510(K)
K
14
3606
MultiBand SENSE
2
Cleared 510(K)
K
15
0427
Vantage Titan 1.5T, V3.1, MRT-1510
2
Cleared 510(K)
K
14
3253
O-MAR
2
Cleared 510(K)
K
14
3008
Vantage Titan 3T
2
Cleared 510(K)
K
14
2421
G-scan Brio
2
Cleared 510(K)
K
14
3128
mDIXON XD
2
Cleared 510(K)
K
14
2734
TRILLIUM Oval MR System
2
Cleared 510(K)
K
14
3251
SIGNA Creator, SIGNA Explorer
2
Cleared 510(K)
K
14
1945
ECHOSTAR COMFORT 1.5T MRI
2
Cleared 510(K)
K
14
2997
RTHawk, HeartVista Workstation with RTHawk
2
Cleared 510(K)
K
14
2361
Discovery MR750 3.0T
2
Cleared 510(K)
K
14
1977
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL
2
Cleared 510(K)
K
13
1737
SUPERNOVA C5 MRI SYSTEM
2
Cleared 510(K)
K
14
2515
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
2
Cleared 510(K)
K
14
2085
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
2
Cleared 510(K)
K
14
1472
VANTAGE ELAN
2
Cleared 510(K)
K
14
0956
LCD MONITOR
2
Cleared 510(K)
K
13
3670
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
2
Cleared 510(K)
K
13
3848
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
2
Cleared 510(K)
K
14
0666
MR ELASTOGRAPHY
2
Cleared 510(K)
K
13
2381
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
2
Cleared 510(K)
K
14
0253
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
2
Cleared 510(K)
K
13
1896
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
13
3526
MDIXON-QUANT
2
Cleared 510(K)
K
13
3692
IMRI 1.5T AND IMRI 3T S
2
Cleared 510(K)
K
13
0692
M2 WRIST 2 MRI SYSTEM
2
Cleared 510(K)
K
13
3490
G-SCAN BRIO
2
Cleared 510(K)
K
13
1996
S-SCAN
2
Cleared 510(K)
K
12
2035
HEPAFAT SCAN
2
Cleared 510(K)
K
13
3435
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
2
Cleared 510(K)
K
13
2119
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
2
Cleared 510(K)
K
13
2951
MAGNETOM AERA
2
Cleared 510(K)
K
13
2376
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
2
Cleared 510(K)
K
13
2831
QUIET/SILENT SCANNING SUITE
2
Cleared 510(K)
K
13
2160
VANTAGE TITAN 3T
2
Cleared 510(K)
K
13
1241
SWIP
2
Cleared 510(K)
K
13
0658
ELIXBO PM545
2
Cleared 510(K)
K
13
0115
DISCOVERY MR750W 3.0T
2
Cleared 510(K)
K
13
0885
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
2
Cleared 510(K)
K
12
3510
MAGNETOM SKYRA
2
Cleared 510(K)
K
12
3522
OPTIMA MR450W
2
Cleared 510(K)
K
13
0262
MAGNETOM ESSENZA WITH SYNGO MR D14
2
Cleared 510(K)
K
12
3938
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN
2
Cleared 510(K)
K
12
0701
M2 WRIST MRI SYSTEM
2
Cleared 510(K)
K
12
3417
BRIVO MR355, OPTIMA MR360
2
Cleared 510(K)
K
12
2613
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
2
Cleared 510(K)
K
11
3394
MAVRIC SL
2
Cleared 510(K)
K
12
2034
MRJ 3300
2
Cleared 510(K)
K
12
3068
OPTIMA MR 430S
2
Cleared 510(K)
K
12
1434
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
2
Cleared 510(K)
K
12
2026
PRISM ACQUIRE PRISM PROCESS PRISM VIEW
2
Cleared 510(K)
K
12
1676
1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
2
Cleared 510(K)
K
12
1997
IMRIS ONCOLOGY PACKAGE
2
Cleared 510(K)
K
12
2006
G-SCAN BRIO
2
Cleared 510(K)
K
12
1160
MAGNETOM SPECTRA
2
Cleared 510(K)
K
12
1650
S-SCAN
2
Cleared 510(K)
K
12
1545
BELLYBOARD, SBRT ACCESSORIES
2
Cleared 510(K)
K
12
0638
VANTAGE TITAN
2
Cleared 510(K)
K
12
1239
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
2
Cleared 510(K)
K
12
0487
VANTAGE TITAN 3T
2
Cleared 510(K)
K
11
3281
MRI SYTEMS
2
Cleared 510(K)
K
11
3511
ECHOSTAR SPICA 1.5T MR SYSTEM
2
Cleared 510(K)
K
12
0748
SPEEDUP SOFTWARE OPTION
2
Cleared 510(K)
K
11
3145
ECHELON OVAL MRI SYSTEM
2
Cleared 510(K)
K
12
0778
BRIVO MR355
2
Cleared 510(K)
K
11
3490
OPTIMA MR450W
2
Cleared 510(K)
K
11
3093
VANTAGE TITAN 3T
2
Cleared 510(K)
K
11
3337
VISIA DYNAMIC REVIEW
2
Cleared 510(K)
K
11
2003
VANTAGE TITAN HSR
2
Cleared 510(K)
K
11
1242
MAGNETOM AERA AND MAGNETOM SKYRA
2
Cleared 510(K)
K
10
3327
DISCOVERY MR750W 3.0T
2
Cleared 510(K)
K
10
2489
VANTAGE TITAN 3T
2
Cleared 510(K)
K
11
0942
PICA WHOLE-BODY MRI SYSTEM
2
Cleared 510(K)
K
11
1803
G-SCAN
2
Cleared 510(K)
K
11
1226
ENDOSCOUT TRACKING SYSTEM
2
Cleared 510(K)
K
11
1340
HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
2
Cleared 510(K)
K
11
0802
A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18
2
Cleared 510(K)
K
11
0151
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
2
Cleared 510(K)
K
10
3411
IDEAL IQ SOFTWARE OPTION
2
Cleared 510(K)
K
11
0238
G-SCAN
2
Cleared 510(K)
K
10
3330
BRIVO MR355, OPTIMA MR360
2
Cleared 510(K)
K
10
3238
1.5T OPTIMA MR430S
2
Cleared 510(K)
K
10
3507
MEDICAL VISORS MV100
2
Cleared 510(K)
K
10
2344
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
2
Cleared 510(K)
K
10
1813
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
2
Cleared 510(K)
K
10
1347
MAGNETOM AERA; MAGNETOM SKYRA
2
Cleared 510(K)
K
10
2155
MR RADIATION ONCOLOGY OPTIONS
2
Cleared 510(K)
K
10
1295
MROPEN
2
Cleared 510(K)
K
09
3738
MRI PATIENT POSITIONING DEVICES
2
Cleared 510(K)
K
10
0164
MR INSPIRE WITH EXTENDED KIT
2
Cleared 510(K)
K
09
3984
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01
2
Cleared 510(K)
K
09
2308
POLESTAR, MODEL N-30
2
Cleared 510(K)
K
10
0352
DIAGNOSOFT HARP MODEL 2.06
2
Cleared 510(K)
K
09
3336
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
2
Cleared 510(K)
K
09
2925
3D ASL
2
Cleared 510(K)
K
09
2469
O-SCAN MR SYSTEM
2
Cleared 510(K)
K
09
2230
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
2
Cleared 510(K)
K
09
2899
OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
2
Cleared 510(K)
K
09
2253
MODIFICATION TO FMRI HARDWARE SYSTEM
2
Cleared 510(K)
K
09
2237
NSM-S15 SYSTEM
2
Cleared 510(K)
K
09
1166
IMRX
2
Cleared 510(K)
K
09
1580
PICA WHOLE BODY MRI SYSTEM
2
Cleared 510(K)
K
08
3421
MR-TOUCH OPTION
2
Cleared 510(K)
K
09
1444
PERFSCAPE
2
Cleared 510(K)
K
09
1536
OPTIMA MR450W
2
Cleared 510(K)
K
09
1669
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
2
Cleared 510(K)
K
09
0038
SYNGO BREVIS
2
Cleared 510(K)
K
09
0873
I OPEN 0.5T
2
Cleared 510(K)
K
09
0433
I_OPEN 0.4T
2
Cleared 510(K)
K
09
0080
CIRRUS OPEN
2
Cleared 510(K)
K
08
2964
PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
2
Cleared 510(K)
K
08
3533
ECHELON C MRI SYSTEM
2
Cleared 510(K)
K
08
3137
NEURO III-SV
2
Cleared 510(K)
K
08
2427
SYNGO MR B17
2
Cleared 510(K)
K
08
3147
DISCOVERY MR450
2
Cleared 510(K)
K
08
2331
MAGNETOM C!
2
Cleared 510(K)
K
07
3425
MODIFICATION TO AURORA MRI SYSTEM
2
Cleared 510(K)
K
08
2485
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
2
Cleared 510(K)
K
08
2100
ALLTECH ECHOSTAR 1.5 T MR SYSTEM
2
Cleared 510(K)
K
08
1916
GE SIGNA MR ONCOLOGY PACKAGE
2
Cleared 510(K)
K
07
3362
MROPEN
2
Cleared 510(K)
K
08
0515
FMRI HARDWARE SYSTEM
2
Cleared 510(K)
K
08
0762
IB NEURO, VERSION 1.0
2
Cleared 510(K)
K
08
0968
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
2
Cleared 510(K)
K
08
1028
SIGNA 3.0T MR750 SYSTEM
2
Cleared 510(K)
K
08
0098
MRJ EXTENDED
2
Cleared 510(K)
K
07
3156
QPLAQUE MR
2
Cleared 510(K)
K
08
0048
MSK EXTREME MR SCANNER, MODEL AA5000
2
Cleared 510(K)
K
07
3457
MSTAR MPD4500
2
Cleared 510(K)
K
08
0038
VANTAGE TITAN, MODEL MRT-1504/S3
2
Cleared 510(K)
K
07
3167
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
2
Cleared 510(K)
K
07
2473
CHASE MR SYSTEM
2
Cleared 510(K)
K
07
3081
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
2
Cleared 510(K)
K
07
2850
MRI SYSTEM, MODEL MAGFINDER II / AI 3200
2
Cleared 510(K)
K
07
3099
FMRI HARDWARE SYSTEM
2
Cleared 510(K)
K
07
0968
CHOY COMPRESSION FRAME
2
Cleared 510(K)
K
07
2998
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
2
Cleared 510(K)
K
07
2237
MAGNETOM VERIO
2
Cleared 510(K)
K
07
2279
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
07
1925
MAGNETOM ESSENZA
2
Cleared 510(K)
K
07
1099
NEURO II-SE, MODELS: OR-DR-OR, OR-MB
2
Cleared 510(K)
K
07
1154
SUPERSTAR 0.35T MRI SYSTEM
2
Cleared 510(K)
K
06
3559
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
2
Cleared 510(K)
K
06
3361
EXCELART VANTAGE ATLAS, MODEL MRT-1503
2
Cleared 510(K)
K
06
3207
S-SCAN MRI SYSTEM
2
Cleared 510(K)
K
06
2454
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
2
Cleared 510(K)
K
06
2860
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
2
Cleared 510(K)
K
06
1916
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
2
Cleared 510(K)
K
06
1930
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
2
Cleared 510(K)
K
06
1368
DIAGNOSOFT HARP
2
Cleared 510(K)
K
06
1429
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
2
Cleared 510(K)
K
06
1255
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
2
Cleared 510(K)
K
06
1132
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
2
Cleared 510(K)
K
06
0956
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
2
Cleared 510(K)
K
05
3309
ALTAIRE INTERVENTIONAL MR PACKAGE
2
Cleared 510(K)
K
06
0003
EXCELART VANTAGE ZGV
2
Cleared 510(K)
K
05
2423
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
2
Cleared 510(K)
K
05
2023
CADIMAS VERSION 1.0
2
Cleared 510(K)
K
05
3009
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
2
Cleared 510(K)
K
05
2978
GE 1.5T SIGNA HDE MR SYSTEM
2
Cleared 510(K)
K
05
2987
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
2
Cleared 510(K)
K
05
2698
MODIFICATION TO: AURORA
2
Cleared 510(K)
K
05
2571
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
2
Cleared 510(K)
K
05
2164
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
2
Cleared 510(K)
K
05
2579
PORTAL GRAVITY SYSTEM
2
Cleared 510(K)
K
05
2172
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
05
2315
SIMTEC IM-MAXX 2 OPTION
2
Cleared 510(K)
K
05
2293
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
2
Cleared 510(K)
K
05
2305
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
2
Cleared 510(K)
K
05
2078
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
2
Cleared 510(K)
K
05
2013
ACHIEVA 1.5T & INERA 1.5T FAMILY
2
Cleared 510(K)
K
05
0602
ALTAIRE
2
Cleared 510(K)
K
05
0237
STARSHIELD V3 RF TRNT
2
Cleared 510(K)
K
05
0200
MAGNETOM TRIO A TIM SYSTEM
2
Cleared 510(K)
K
05
0199
MAGNETOM SYMPHONY A TIM SYSTEM
2
Cleared 510(K)
K
05
0132
NEURO II-S
2
Cleared 510(K)
K
04
3147
ACHIEVA FAMILY
2
Cleared 510(K)
K
04
3290
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
2
Cleared 510(K)
K
04
3271
R2-MRI ANALYSIS SYSTEM
2
Cleared 510(K)
K
04
3262
GE SIGNA EXCITE MR SURGICAL OPTION
2
Cleared 510(K)
K
04
3030
MAGNETOM C! MR SYSTEM
2
Cleared 510(K)
K
04
3112
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
2
Cleared 510(K)
K
04
2948
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
04
2236
G-SCAN
2
Cleared 510(K)
K
04
1602
PANORAMA 1.0T
2
Cleared 510(K)
K
04
1695
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
2
Cleared 510(K)
K
04
1286
DYNACAD V1.0
2
Cleared 510(K)
K
04
1112
MAGNETOM ESPREE SYSTEM
2
Cleared 510(K)
K
04
1111
MAGNETOM C! MR SYSTEM
2
Cleared 510(K)
K
04
1020
CADSTREAM VERSION 3.1
2
Cleared 510(K)
K
04
1577
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
2
Cleared 510(K)
K
04
1476
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
2
Cleared 510(K)
K
04
0877
ARTOSCAN C
2
Cleared 510(K)
K
03
3485
ENDOSCOUT
2
Cleared 510(K)
K
04
0444
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
2
Cleared 510(K)
K
03
3507
MRJ
2
Cleared 510(K)
K
03
3867
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
2
Cleared 510(K)
K
03
3504
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
2
Cleared 510(K)
K
03
3315
SUPEROPEN 0.23T, MODEL NAM-P023A
2
Cleared 510(K)
K
03
2428
MAGNETOM AVANTO MR SYSTEM
2
Cleared 510(K)
K
03
3168
GE 0.2T SIGNA PROFILE/I MR SYSTEM
2
Cleared 510(K)
K
03
2795
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
2
Cleared 510(K)
K
03
2232
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
2
Cleared 510(K)
K
03
2678
MODIFICATION TO: AURORA
2
Cleared 510(K)
K
03
2541
POLESTAR N-20
2
Cleared 510(K)
K
03
1815
INTERA-SENSATION FAMILY
2
Cleared 510(K)
K
03
2490
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
2
Cleared 510(K)
K
03
2121
MODIFICATION TO E-SCAN XQ
2
Cleared 510(K)
K
03
2082
AURORA
2
Cleared 510(K)
K
03
1731
MR FIBER OPTIC ECG GATING SYSTEM
2
Cleared 510(K)
K
03
1927
GE DELTA SOFTWARE OPTION FOR MRI
2
Cleared 510(K)
K
03
0981
ECLIPSE
2
Cleared 510(K)
K
03
1350
3TP SOFTWARE OPTION
2
Cleared 510(K)
K
03
1396
ADVANTAGE WORKSTATION PASTING 1.1
2
Cleared 510(K)
K
03
1230
GE PROPELLER IMAGING OPTION FOR MRI
2
Cleared 510(K)
K
03
0918
SUPEROPEN 0.35T, MODEL NSM-P035
2
Cleared 510(K)
K
03
0874
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
2
Cleared 510(K)
K
03
0520
INTERA FAMILY
2
Cleared 510(K)
K
02
4066
INFINION SOFTWARE FEATURES
2
Cleared 510(K)
K
02
4042
PANORAMA ENHANCEMENTS
2
Cleared 510(K)
K
02
3686
AURORA MR-GUIDED INTERVENTIONAL SYSTEM
2
Cleared 510(K)
K
02
3511
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
2
Cleared 510(K)
K
02
3130
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
2
Cleared 510(K)
K
02
2390
HITACHI ALTAIRE
2
Cleared 510(K)
K
02
3207
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
2
Cleared 510(K)
K
02
2157
RF TENT
2
Cleared 510(K)
K
02
2397
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
02
0991
SYNGO MR 2002B
2
Cleared 510(K)
K
02
0268
ISAAC 1.5 T MR SYSTEM
2
Cleared 510(K)
K
02
0289
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
2
Cleared 510(K)
K
02
0573
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM
2
Cleared 510(K)
K
02
0164
E-SCAN XQ
2
Cleared 510(K)
K
01
4011
CANVAS N-VAS-D 2.0
2
Cleared 510(K)
K
01
3636
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
2
Cleared 510(K)
K
01
3858
INFINION 0.6T MR IMAGING SYSTEM
2
Cleared 510(K)
K
01
3586
MAGNETOM TRIO SYSTEM
2
Cleared 510(K)
K
01
0850
POLESTAR N-10
2
Cleared 510(K)
K
01
3344
INTERA I/T
2
Cleared 510(K)
K
01
2875
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
01
2495
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
2
Cleared 510(K)
K
01
3150
MR-GUIDE 2000
2
Cleared 510(K)
K
01
2202
NUMARIS 4VA15A
2
Cleared 510(K)
K
01
2970
GE SIGNA ASSET IMAGING OPTION
2
Cleared 510(K)
K
01
2154
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
01
1416
MUSCLE IMAGING SYSTEM (MIS)
2
Cleared 510(K)
K
01
2200
1.5T INFINITY TWINSPEED MR SYSTEM
2
Cleared 510(K)
K
01
1296
INFINION ENHANCEMENT PACKAGE
2
Cleared 510(K)
K
01
1485
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
2
Cleared 510(K)
K
01
1466
QED DIODE DETECTORS, MODELS 1112-1116
2
Cleared 510(K)
K
01
0773
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
2
Cleared 510(K)
K
01
1418
ULTRAGUIDE MR-GUIDE 3000
2
Cleared 510(K)
K
01
0691
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
2
Cleared 510(K)
K
00
2997
FIESTA IMAGING OPTION
2
Cleared 510(K)
K
01
0570
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
2
Cleared 510(K)
K
00
3899
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
2
Cleared 510(K)
K
00
3947
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
2
Cleared 510(K)
K
00
3651
AURORA
2
Cleared 510(K)
K
00
3853
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
2
Cleared 510(K)
K
01
0057
MODIFICATION TO ARTOSCAN M
2
Cleared 510(K)
K
00
3628
MAGNETOM RHAPSODY SYSTEM
2
Cleared 510(K)
K
00
3573
DIFFUSION TENSOR IMAGING OPTION
2
Cleared 510(K)
K
00
3453
SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
2
Cleared 510(K)
K
00
3516
GYROSCAN INTERA 3.0T
2
Cleared 510(K)
K
00
3623
INTERACTIVE REAL TIME SCANNING PACKAGE
2
Cleared 510(K)
K
00
3192
MAGNETIC CONCERTO
2
Cleared 510(K)
K
00
2964
NEURO II
2
Cleared 510(K)
K
00
2611
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
00
2531
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
2
Cleared 510(K)
K
00
2420
HITACHI ALTAIRE
2
Cleared 510(K)
K
00
2179
MAGNETOM ALLEGRA SYSTEM
2
Cleared 510(K)
K
00
2490
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
2
Cleared 510(K)
K
00
2242
POLESTAR N-10
2
Cleared 510(K)
K
00
1987
EXPLORER GRADIENT
2
Cleared 510(K)
K
00
1796
GYROSCAN INTERA (R7.5)
2
Cleared 510(K)
K
99
4283
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
2
Cleared 510(K)
K
00
2415
POWERDRIVE 350 OPTION
2
Cleared 510(K)
K
00
1773
ORTHONE
2
Cleared 510(K)
K
00
2225
OR TABLE/MAGNETOM OPEN VIVA SYSTEM
2
Cleared 510(K)
K
00
1894
MODIFICATION TO E-SCAN
2
Cleared 510(K)
K
00
1334
HITACHI AIRIS II
2
Cleared 510(K)
K
00
0802
SPIRAL IMAGING OPTION
2
Cleared 510(K)
K
00
0832
STEROTACTIC LOCALIZATION DEVICE (SLD)
2
Cleared 510(K)
K
00
0315
VENTRICULAR ANALYSIS TOOLKIT OPTION
2
Cleared 510(K)
K
99
4351
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
2
Cleared 510(K)
K
99
4287
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
2
Cleared 510(K)
K
99
4282
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
2
Cleared 510(K)
K
99
3803
EXCELART WITH PIANISSIMO
2
Cleared 510(K)
K
99
4117
MR ENHANCER
2
Cleared 510(K)
K
99
3682
MRI EQUIPMENT COVER
2
Cleared 510(K)
K
99
3574
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
2
Cleared 510(K)
K
99
4316
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
2
Cleared 510(K)
K
99
3731
SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
2
Cleared 510(K)
K
99
0329
PHILIPS EASYVISION WORKSTATION
2
Cleared 510(K)
K
99
2746
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
99
0826
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
2
Cleared 510(K)
K
99
2533
PHILIPS GYROSCAN INTERA (*)
2
Cleared 510(K)
K
99
0153
VIRGO MRI SYSTEM
2
Cleared 510(K)
K
98
3793
PREFERENCE TREATMENT SYSTEM
2
Cleared 510(K)
K
99
2892
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
2
Cleared 510(K)
K
99
0335
PHILIPS EASYVISION WORKSTATION:
2
Cleared 510(K)
K
99
2135
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
99
2225
QUANTITATIVE FLOW
2
Cleared 510(K)
K
99
1943
MRGP OPTICAL TRACKING UNIT
2
Cleared 510(K)
K
99
2412
IPASS BOLUS TRACKING
2
Cleared 510(K)
K
99
2120
DYNAWELL OR DYNAWELL
2
Cleared 510(K)
K
99
1652
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
2
Cleared 510(K)
K
99
1243
NORMA 10
2
Cleared 510(K)
K
99
0968
E-SCAN
2
Cleared 510(K)
K
99
0620
EXCELART
2
Cleared 510(K)
K
99
0550
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
99
0260
OPART
2
Cleared 510(K)
K
98
3110
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
2
Cleared 510(K)
K
98
4221
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
2
Cleared 510(K)
K
98
4280
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
2
Cleared 510(K)
K
98
4224
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
2
Cleared 510(K)
K
98
4274
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
2
Cleared 510(K)
K
98
3902
FIELD EFFECTS MRI SYSTEM
2
Cleared 510(K)
K
98
2959
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
2
Cleared 510(K)
K
98
2932
MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC
2
Cleared 510(K)
K
98
2834
RESTGRID PACKAGE/GYROSCAN NT
2
Cleared 510(K)
K
98
2761
JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031
2
Cleared 510(K)
K
98
3327
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
2
Cleared 510(K)
K
98
2157
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
98
0831
IMAGE POST-PROCESSING TECHNIQUES
2
Cleared 510(K)
K
98
1898
ORTHOVU-1000
2
Cleared 510(K)
K
98
1475
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE
2
Cleared 510(K)
K
98
1410
HAMMERSMITH ENDOCAVITARY COILS
2
Cleared 510(K)
K
98
1190
HIGH IMPEDANCE CARDIAC GATING CABLE
2
Cleared 510(K)
K
98
1398
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
2
Cleared 510(K)
K
98
0645
PHILIPS GYROSCAN NT RELEASE 6 SERIES
2
Cleared 510(K)
K
97
3658
DIFFUSION PACKAGE / GYROSCAN NT
2
Cleared 510(K)
K
98
0417
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V
2
Cleared 510(K)
K
98
0306
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
2
Cleared 510(K)
K
98
0114
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
97
4844
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
2
Cleared 510(K)
K
97
4614
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102
2
Cleared 510(K)
K
97
4498
STRATIS II
2
Cleared 510(K)
K
97
4212
AIRIS II
2
Cleared 510(K)
K
97
4530
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
2
Cleared 510(K)
K
97
2990
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
97
3799
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
2
Cleared 510(K)
K
97
2826
ESTEEM 1.5T MRI SYSTEM
2
Cleared 510(K)
K
97
2704
KINEMATIC POSITIONERS
2
Cleared 510(K)
K
97
0990
GYREX PRIMA 1TG 1.0T MRI SYSTEM
2
Cleared 510(K)
K
97
1884
ASSET APOLLO
2
Cleared 510(K)
K
97
1684
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
2
Cleared 510(K)
K
97
1668
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
2
Cleared 510(K)
K
97
0573
FLEXART V3.5 SOFTWARE
2
Cleared 510(K)
K
96
5068
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
2
Cleared 510(K)
K
97
1380
MEDRAD FLEX INTERFACE DEVICE
2
Cleared 510(K)
K
97
1279
VERSION 4 OPERATING SYSTEM SOFTWARE
2
Cleared 510(K)
K
97
1055
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
2
Cleared 510(K)
K
96
5044
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
2
Cleared 510(K)
K
97
0852
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
2
Cleared 510(K)
K
96
3990
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
2
Cleared 510(K)
K
96
3262
ARTOSCAN M
2
Cleared 510(K)
K
97
0037
TARGOGRID
2
Cleared 510(K)
K
96
4778
HI-STAR MRI IMAGING SYSTEM
2
Cleared 510(K)
K
96
4752
KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER
2
Cleared 510(K)
K
96
4753
MATRIX 3000 FLEXIBLE SPINE COIL
2
Cleared 510(K)
K
96
4626
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
2
Cleared 510(K)
K
96
4608
MRT-35A V9.0
2
Cleared 510(K)
K
96
4531
PROFILE 70000 QUADRATURE VOLUME NECK COIL
2
Cleared 510(K)
K
96
4306
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
96
4370
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
96
2249
PIXELL MRI SYSTEM
2
Cleared 510(K)
K
96
2138
FLEXART V3.1 SOFTWARE
2
Cleared 510(K)
K
96
3953
IMIG-MRI
2
Cleared 510(K)
K
96
3429
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
96
2061
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
96
3186
ORTHO 8000
2
Cleared 510(K)
K
96
3179
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
96
2892
HELAX TMS BRACHYTHERAPY, VERSION 3.0
2
Cleared 510(K)
K
96
2933
OPART MRT-600
2
Cleared 510(K)
K
96
3345
ADVANTAGE WINDOWS TISSUE VOLUME OPTION
2
Cleared 510(K)
K
96
1624
FLEXART TMJ COIL
2
Cleared 510(K)
K
96
2927
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
2
Cleared 510(K)
K
96
2677
ESTEEM 1.5T MRI SYSTEM
2
Cleared 510(K)
K
96
1969
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE
2
Cleared 510(K)
K
96
2618
GYREX V-EP
2
Cleared 510(K)
K
96
2117
QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
2
Cleared 510(K)
K
96
2048
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
2
Cleared 510(K)
K
96
1842
SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
96
1876
AIRIS
2
Cleared 510(K)
K
96
0497
FLEXIBLE PHASED ARRAY SPINE COIL
2
Cleared 510(K)
K
96
1366
MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
2
Cleared 510(K)
K
96
1238
MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1
2
Cleared 510(K)
K
96
1174
ECG MONITOR MODEL DS-3130/3140
2
Cleared 510(K)
K
96
1121
KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
2
Cleared 510(K)
K
96
1092
VISART
2
Cleared 510(K)
K
95
5389
MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
2
Cleared 510(K)
K
96
0973
MOVABLE ADD-ON COUCH FOR OUTLOOK
2
Cleared 510(K)
K
96
0901
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
2
Cleared 510(K)
K
96
0294
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
2
Cleared 510(K)
K
95
4353
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
95
4354
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
95
5811
AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
2
Cleared 510(K)
K
96
0181
VERSION 3.7 OPERATING SYSTEM SOFTWARE
2
Cleared 510(K)
K
95
0837
AURORA IMAGING SYSTEM
2
Cleared 510(K)
K
95
4646
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
2
Cleared 510(K)
K
94
5945
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
2
Cleared 510(K)
K
95
4039
GYREX PRIVILEGE
2
Cleared 510(K)
K
94
2604
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
95
4355
ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
2
Cleared 510(K)
K
95
1650
CLINICAL PROTON SPECTROSCOPY OPTION
2
Cleared 510(K)
K
95
1681
QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER
2
Cleared 510(K)
K
95
3248
IRIS BILATERAL TMJ
2
Cleared 510(K)
K
95
3262
QD BILATERAL BREAST COIL
2
Cleared 510(K)
K
94
5517
MAGNETOM VISION (PROJECT 016)
2
Cleared 510(K)
K
94
3440
PROFILE 7000 C-SPINE COIL
2
Cleared 510(K)
K
94
5791
GYRES 2T PRESTIGE
2
Cleared 510(K)
K
94
5827
OUTLOOK
2
Cleared 510(K)
K
95
3918
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
94
4724
HEALTH IMAGE INC. HI STAR
2
Cleared 510(K)
K
94
5779
MAGNETOM VISION (PROJECT 016)
2
Cleared 510(K)
K
94
5730
SIGNA PROFILE
2
Cleared 510(K)
K
94
3189
MEDRAD QWIK-FIX MRI DISPOSABLE KIT
2
Cleared 510(K)
K
95
2530
HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE
2
Cleared 510(K)
K
94
4228
HEALTH IMAGES, INC. HI-STANDARD
2
Cleared 510(K)
K
95
2235
MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15
2
Cleared 510(K)
K
95
2232
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15
2
Cleared 510(K)
K
95
1649
MODEL #801GE1500 PEDIATRIC ARRAY COIL
2
Cleared 510(K)
K
94
4070
ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING
2
Cleared 510(K)
K
94
1666
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS
2
Cleared 510(K)
K
94
4979
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
94
6085
THIN-FILM CARDIAC GATING CABLE
2
Cleared 510(K)
K
94
5155
AIRIS
2
Cleared 510(K)
K
94
3798
MRH-1500
2
Cleared 510(K)
K
95
0973
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
94
5875
MRT-50 QD BODY COIL
2
Cleared 510(K)
K
94
5828
ECHO PLANAR IMAGING I
2
Cleared 510(K)
K
94
0772
ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)
2
Cleared 510(K)
K
94
5798
MRT-35A UPGRADE 8.0CD
2
Cleared 510(K)
K
94
5665
FLEXART(TM) QD C-SPINE COIL
2
Cleared 510(K)
K
94
5778
PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
2
Cleared 510(K)
K
94
5386
STRATIS
2
Cleared 510(K)
K
94
5397
ANGIO II
2
Cleared 510(K)
K
94
6244
ACCESS(TM) COMPASS BED
2
Cleared 510(K)
K
94
2669
SMT-50CX/H
2
Cleared 510(K)
K
94
1864
MRT-150A, MRT-150A SOFTWARE VERSION 11.9
2
Cleared 510(K)
K
94
1622
ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION
2
Cleared 510(K)
K
94
4773
MODEL 405GE-64: PHASED ARRAY TMJ COIL
2
Cleared 510(K)
K
94
4662
FLEXART QD BODY COIL
2
Cleared 510(K)
K
94
4469
GENERAL PURPOSE FLEX COIL
2
Cleared 510(K)
K
94
4331
MODEL 528GE SERIES
2
Cleared 510(K)
K
94
3800
2D,3D, TOF MR ANGIOGRAPHY
2
Cleared 510(K)
K
94
1582
SUPERSENSOR MRI COIL
2
Cleared 510(K)
K
94
4112
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
94
3415
MERIT (O.1T MR SYSTEM)
2
Cleared 510(K)
K
94
3799
VERSION 5 OPERATING SYSTEM SOFTWARE
2
Cleared 510(K)
K
94
2874
MODEL #300TO3500 SHOULDER COIL
2
Cleared 510(K)
K
94
2875
MODEL #900TO3500 HEAD/NECK COIL
2
Cleared 510(K)
K
94
2873
MODEL #700TO3500 NECK/ABDOMINAL COIL
2
Cleared 510(K)
K
94
3320
HEAD AND NECK COIL FOR THE GYREX 2T-DLX
2
Cleared 510(K)
K
94
0534
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)
2
Cleared 510(K)
K
94
0541
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)
2
Cleared 510(K)
K
94
3021
MRT-150A
2
Cleared 510(K)
K
94
2953
ORACLE MRI WHOLE BODY MR IMAGING SYSTEM
2
Cleared 510(K)
K
94
3321
QUAD PELVIS COIL
2
Cleared 510(K)
K
94
2776
MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1
2
Cleared 510(K)
K
94
2355
MODEL #310T03500 WRIST COIL
2
Cleared 510(K)
K
93
4987
CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX
2
Cleared 510(K)
K
94
2560
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
94
2609
MRT-150A SHOULDER COIL
2
Cleared 510(K)
K
94
0894
MAGNA SL
2
Cleared 510(K)
K
94
1996
EDGE
2
Cleared 510(K)
K
93
5549
GYREX 2T-SGR
2
Cleared 510(K)
K
94
0796
ACCESS
2
Cleared 510(K)
K
93
4318
DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL
2
Cleared 510(K)
K
94
1812
SLICES
2
Cleared 510(K)
K
93
5691
MODEL GP-252 GENERAL PURPOSE COIL
2
Cleared 510(K)
K
94
1408
MERIT
2
Cleared 510(K)
K
93
5224
VOLUME NECK COIL FOR THE GYREX V-DIX
2
Cleared 510(K)
K
93
0193
PHILIPS ENDO-CAVITARY MRI COIL
2
Cleared 510(K)
K
94
0364
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
93
4514
CATCH AND HOLD OPTION FOR INSTASCAN
2
Cleared 510(K)
K
94
1025
PHASED ARRAY BREAST COIL
2
Cleared 510(K)
K
94
0874
MODEL 900GE1500 HEAD/NECK COIL
2
Cleared 510(K)
K
94
0602
EXTRA LARGE QUAD FLEX SPINE COIL
2
Cleared 510(K)
K
93
5015
QUADRATURE SMALL EXTREMITY COIL
2
Cleared 510(K)
K
94
0514
41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15
2
Cleared 510(K)
K
93
4538
MRI RESONANCE DIAGNOSTIC DEVICE ACCESORY
2
Cleared 510(K)
K
93
5670
VERSION 3 OPERATING SYSTEM SOFTWARE
2
Cleared 510(K)
K
93
5671
2D, 3D TOF MR ANGIOGRAPHY
2
Cleared 510(K)
K
93
5752
CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS
2
Cleared 510(K)
K
93
5627
CP BODY ARRAY/ CP SPINE ARRAY COIL
2
Cleared 510(K)
K
93
5450
PHASED ARRAY PELVIC COIL
2
Cleared 510(K)
K
93
5369
FAST SPIN ECHO (FSE)
2
Cleared 510(K)
K
93
3296
MODEL #310GE1500 WRIST COIL
2
Cleared 510(K)
K
93
3295
MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA
2
Cleared 510(K)
K
93
5661
MAGNETOM OPEN
2
Cleared 510(K)
K
93
5664
FAST SPIN ECHO
2
Cleared 510(K)
K
93
5570
NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
93
1460
VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
93
2403
AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN
2
Cleared 510(K)
K
93
3018
MRT-50GP
2
Cleared 510(K)
K
93
2244
SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
93
5084
INCREASED SAR PACKAGE FOR MRT-150A
2
Cleared 510(K)
K
93
2552
SPORTS MEDICINE QUADRATURE SHOULDER COIL
2
Cleared 510(K)
K
93
4485
HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION
2
Cleared 510(K)
K
93
0708
PHILIPS GYROSCAN T5 II RELEASE 3
2
Cleared 510(K)
K
93
1298
SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
93
2271
MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016
2
Cleared 510(K)
K
93
4719
EXTRA LARGE QUAD FLEX SPINE COIL
2
Cleared 510(K)
K
93
4212
FAST SPIN ECHO
2
Cleared 510(K)
K
93
4499
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
93
3356
MERIT
2
Cleared 510(K)
K
93
2091
PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL
2
Cleared 510(K)
K
93
1656
MERIT
2
Cleared 510(K)
K
93
1454
IMAGEACCESS SYSTEM
2
Cleared 510(K)
K
93
2645
PHILIPS GYROSCAN TN 15
2
Cleared 510(K)
K
93
2644
PHILIPS GYROSCAN TN5 & TN5 LITE
2
Cleared 510(K)
K
92
5858
OE 1.5 SI
2
Cleared 510(K)
K
93
4396
QUADRATURE LOWER EXTREMITY COIL
2
Cleared 510(K)
K
93
3835
0.5T ASSET SYSTEM
2
Cleared 510(K)
K
93
3659
MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL
2
Cleared 510(K)
K
93
1544
1.5T EDGE AND 1.0T VISTA SYSTEMS
2
Cleared 510(K)
K
93
3658
MODEL 300GE1500 SHOULDER COIL
2
Cleared 510(K)
K
93
3645
ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000
2
Cleared 510(K)
K
93
0709
PHILIPS GYROSCAN ACS-II RELEASE 3
2
Cleared 510(K)
K
93
3297
MODEL #510GE1500 LIVER ARRAY COIL
2
Cleared 510(K)
K
93
1392
ECG GATING UNIT
2
Cleared 510(K)
K
93
0960
ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY
2
Cleared 510(K)
K
92
6275
PHILIPS MRI BREAST COIL
2
Cleared 510(K)
K
93
2344
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
2
Cleared 510(K)
K
92
6001
MRT-50A, MRT-150A
2
Cleared 510(K)
K
93
2693
EDGE SYSTEM
2
Cleared 510(K)
K
93
1022
ARTOSCAN
2
Cleared 510(K)
K
93
0779
MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15
2
Cleared 510(K)
K
92
5985
GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
2
Cleared 510(K)
K
92
5597
SNR-3000 UPGRADE RECEIVER COILS
2
Cleared 510(K)
K
92
5286
MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE
2
Cleared 510(K)
K
93
0544
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15
2
Cleared 510(K)
K
93
0674
MODEL 640GE-64: QUADRATURE PELVIC COIL
2
Cleared 510(K)
K
93
2374
MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL
2
Cleared 510(K)
K
93
2375
MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI
2
Cleared 510(K)
K
93
0811
MODIFIED BODY HELMHOLTZ COIL
2
Cleared 510(K)
K
93
2338
MAGNETOM P8
2
Cleared 510(K)
K
93
2292
AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS
2
Cleared 510(K)
K
93
0122
MODEL 600GE-64: BILATERAL BREAST COIL
2
Cleared 510(K)
K
93
0045
MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL
2
Cleared 510(K)
K
92
6571
MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15
2
Cleared 510(K)
K
93
1008
MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL
2
Cleared 510(K)
K
93
0991
BILATERAL TEMPORAL MANDIBULAR JOINT COIL
2
Cleared 510(K)
K
92
2846
MRH-1500
2
Cleared 510(K)
K
92
4605
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
92
6416
SAT PAD(TM)
2
Cleared 510(K)
K
92
5987
INSTRUMENTARIUM MEGA4 HT
2
Cleared 510(K)
K
92
5029
MRINNERVU ENDORECTAL PROSTATE COIL
2
Cleared 510(K)
K
92
4921
INSTRUMENTARIUM MEGA4 HT
2
Cleared 510(K)
K
92
1891
SILENT SCAN
2
Cleared 510(K)
K
92
4472
INSTRUMENTARIUM MEGA4 HT
2
Cleared 510(K)
K
92
3581
INSTRUMENTARIUM MEGA4 HT
2
Cleared 510(K)
K
92
6171
MRT-150A, QD SPINE COIL
2
Cleared 510(K)
K
92
4808
MRT-50A SUPER
2
Cleared 510(K)
K
92
3944
PHILIPS GYROVIEW HR - RELEASE 2
2
Cleared 510(K)
K
92
6397
FAST SPIN ECHO MEASURING FUNCTION
2
Cleared 510(K)
K
92
3984
SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
92
5009
2D TOF ANGIOGRAHY MEASURING FUNCTION
2
Cleared 510(K)
K
92
5845
VISTA HP/HPQ SYSTEM
2
Cleared 510(K)
K
92
5107
SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
92
4489
SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST
2
Cleared 510(K)
K
92
3870
3DTOF MRA
2
Cleared 510(K)
K
92
4756
MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL
2
Cleared 510(K)
K
92
4653
MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL
2
Cleared 510(K)
K
92
4479
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
2
Cleared 510(K)
K
92
3423
QUADATURE HEAD/NECK/VASCULAR COIL
2
Cleared 510(K)
K
92
3140
MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
2
Cleared 510(K)
K
92
1653
VECTRA MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
92
4426
MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG
2
Cleared 510(K)
K
92
4349
GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP
2
Cleared 510(K)
K
92
3025
SIGNA BREAST COIL AND ARRAY ACCESSORY
2
Cleared 510(K)
K
92
2470
IES, IMAGE ENHANCEMENT SYSTEM
2
Cleared 510(K)
K
92
4154
KINEMATIC MRI MOVIEMAKER
2
Cleared 510(K)
K
92
1940
MRT-35(TM)
2
Cleared 510(K)
K
92
1941
SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT
2
Cleared 510(K)
K
92
3948
SAT PAD
2
Cleared 510(K)
K
92
0791
GYROSCAN S15/ACS-II
2
Cleared 510(K)
K
92
0578
PHILIPS GYROSCAN T5 SERIES II
2
Cleared 510(K)
K
92
3881
QUADRATURE CERVICAL CONTOUR COIL
2
Cleared 510(K)
K
92
3823
3D IMAGING
2
Cleared 510(K)
K
92
3897
A BREAST COIL FOR THE GYREX 2T-DIX
2
Cleared 510(K)
K
92
3615
VISTA HPQ SYSTEM
2
Cleared 510(K)
K
92
3352
INSTRUMENTARIUM MEGA4 HT
2
Cleared 510(K)
K
92
3264
GENERAL PURPOSE FLEX COIL
2
Cleared 510(K)
K
92
3022
INSTRUMENTARIUM MEGA4 HT
2
Cleared 510(K)
K
92
2798
QD WHOLE BODY COIL, MRT-150A
2
Cleared 510(K)
K
92
2677
MAGNETIZATION TRANSFER CONTRAST
2
Cleared 510(K)
K
92
3010
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
92
0227
QUADRATURE SHOULDER CONTOUR COIL
2
Cleared 510(K)
K
92
0714
VISTA HPQ SYSTEM
2
Cleared 510(K)
K
92
1413
MRT-50
2
Cleared 510(K)
K
92
0204
INSTASCAN
2
Cleared 510(K)
K
92
0441
3D TOF ANGIOGRAPHY MEASURING FUNCTION
2
Cleared 510(K)
K
92
2006
QQUADRATURE LUMBAR CONTOUR COIL
2
Cleared 510(K)
K
92
2000
MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL
2
Cleared 510(K)
K
92
1881
VISTA HPQ SYSTEM
2
Cleared 510(K)
K
92
1720
MRT-50A QD SPINE COIL
2
Cleared 510(K)
K
92
0543
MRI OE 1.5 SI
2
Cleared 510(K)
K
92
0096
MRT-150 QD KNEE COIL
2
Cleared 510(K)
K
92
0789
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
2
Cleared 510(K)
K
92
0254
COILS FOR RX4000 & RX5000 MRI SYSTEMS
2
Cleared 510(K)
K
92
1609
VISTA HP/HPQ SYSTEM
2
Cleared 510(K)
K
92
0098
ACCESS QD HEAD COIL
2
Cleared 510(K)
K
92
1046
BO POWER SUPPLY
2
Cleared 510(K)
K
92
0835
PRESATURATION
2
Cleared 510(K)
K
92
1098
MAGNETOM 63SP
2
Cleared 510(K)
K
92
0094
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
2
Cleared 510(K)
K
91
5567
MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY)
2
Cleared 510(K)
K
92
0095
MRT-50 MULTIVIEW COIL
2
Cleared 510(K)
K
92
0215
INSTRUMENTARIUM MEGA4 HT
2
Cleared 510(K)
K
92
0126
MRT-50 FLEXIBLE BODY COIL
2
Cleared 510(K)
K
92
0125
MRT-50 SPINE COIL
2
Cleared 510(K)
K
92
0097
MRT-50 QD HEAD COIL
2
Cleared 510(K)
K
91
5754
16 BIT A/D
2
Cleared 510(K)
K
91
5873
MOS-III
2
Cleared 510(K)
K
91
5260
MRI ULTRAVIEW
2
Cleared 510(K)
K
91
5657
MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28
2
Cleared 510(K)
K
92
0199
HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST
2
Cleared 510(K)
K
92
0159
MOBILE MRP-7000
2
Cleared 510(K)
K
91
4209
MODEL 310GE-64: WHOLE VOLUME NECK COIL
2
Cleared 510(K)
K
91
5552
INSTRUMENTARIUM MEGA4
2
Cleared 510(K)
K
91
5579
3D PROCESSING OPTIONS FOR GYREX
2
Cleared 510(K)
K
91
5601
GYREX 2T-DLX
2
Cleared 510(K)
K
91
5598
SPECIAL PURPOSE COILS FOR GYREX V
2
Cleared 510(K)
K
91
5395
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
2
Cleared 510(K)
K
91
3673
VECTRA MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
91
5112
MAGNETOM 42 SP,63 SP,IMPACT
2
Cleared 510(K)
K
91
3770
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
2
Cleared 510(K)
K
91
4114
2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)
2
Cleared 510(K)
K
91
3463
MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN
2
Cleared 510(K)
K
91
4536
MODELS 190GE-64/191GE-64/192GE-64/193GE-64
2
Cleared 510(K)
K
91
4535
MODEL 311GE-64: WHOLE VOLUME NECK COIL
2
Cleared 510(K)
K
91
4012
MRT-150A
2
Cleared 510(K)
K
91
3869
RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM
2
Cleared 510(K)
K
91
4263
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
2
Cleared 510(K)
K
91
1993
MRH-500
2
Cleared 510(K)
K
91
1872
PHILIPS RIGID VOLUME COILS
2
Cleared 510(K)
K
91
4019
MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
2
Cleared 510(K)
K
91
3325
40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE
2
Cleared 510(K)
K
91
3475
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
91
1975
SMT-100X
2
Cleared 510(K)
K
91
3441
MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT
2
Cleared 510(K)
K
91
2963
INSTRUMENTARIUM MEGA4
2
Cleared 510(K)
K
91
2539
SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
91
3534
VISTA HPQ SYSTEM
2
Cleared 510(K)
K
91
3563
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY
2
Cleared 510(K)
K
91
1959
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF
2
Cleared 510(K)
K
91
2881
GE MR MAX
2
Cleared 510(K)
K
91
1746
H.I.STANDARD CALIBRE UPGRADE
2
Cleared 510(K)
K
91
2410
COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM
2
Cleared 510(K)
K
91
2095
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
91
0839
ULTIMATE 3000
2
Cleared 510(K)
K
91
1991
MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
90
5578
VIEWNET
2
Cleared 510(K)
K
91
1800
COIL FIELD EXTENDER
2
Cleared 510(K)
K
91
1806
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
91
1276
MAGNETIC RESONANCE DEVICE ACCESSORY
2
Cleared 510(K)
K
91
1495
MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
2
Cleared 510(K)
K
91
1348
RIGID ENDOSCOPE
2
Cleared 510(K)
K
91
1892
RX-5000 MRI SYSTEM
2
Cleared 510(K)
K
91
0715
VISTA HPQ SYSTEM
2
Cleared 510(K)
K
91
1667
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
2
Cleared 510(K)
K
91
1642
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
2
Cleared 510(K)
K
91
0802
POWER SCAN 1000
2
Cleared 510(K)
K
91
0817
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR
2
Cleared 510(K)
K
90
5634
SMT-50X
2
Cleared 510(K)
K
91
0269
10 ADJUSTABLE BELT COIL
2
Cleared 510(K)
K
91
0498
MAGNETOM 42 SP AND 63 SP
2
Cleared 510(K)
K
91
0220
MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL
2
Cleared 510(K)
K
91
0514
MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER
2
Cleared 510(K)
K
91
0513
MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER
2
Cleared 510(K)
K
90
5603
PHILIPS GYROVIEW-HR IMAGING WORKSTATION
2
Cleared 510(K)
K
90
5512
ANTERIOR NECK CONTOUR COIL
2
Cleared 510(K)
K
90
5832
MRP -5000(1): VERSION 2.0 SOFTWARE
2
Cleared 510(K)
K
90
5833
MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY
2
Cleared 510(K)
K
90
5835
MRP-7000: SUPPLEMENTAL R/F COILS
2
Cleared 510(K)
K
90
5834
MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY
2
Cleared 510(K)
K
90
5366
MAGNETOM SP/AS (ACTIVELY SHIELDED)
2
Cleared 510(K)
K
90
5858
CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION
2
Cleared 510(K)
K
90
5615
MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL
2
Cleared 510(K)
K
90
5259
VISTA HPQ SYSTEM
2
Cleared 510(K)
K
90
5095
MODEL 3100-21: QUADRATURE SPINE COIL
2
Cleared 510(K)
K
90
5104
MODEL 3100-64: QUADRATURE SPINE COIL
2
Cleared 510(K)
K
90
5070
VISTAR
2
Cleared 510(K)
K
90
5442
MRT35-SP
2
Cleared 510(K)
K
90
5441
MRT 35-A (TM)
2
Cleared 510(K)
K
90
4528
INSTRUMENTARIUM MEGA4, MODIFICATION
2
Cleared 510(K)
K
90
4327
ADVANCED C- SPINE COIL
2
Cleared 510(K)
K
90
3768
MAGNETIC RESONANCE DEVICE MRT 150A
2
Cleared 510(K)
K
90
3770
MRT 50A
2
Cleared 510(K)
K
90
3318
MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30
2
Cleared 510(K)
K
90
3661
BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD
2
Cleared 510(K)
K
90
3754
CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED
2
Cleared 510(K)
K
90
3755
CAT/ #4100-21 SHOULDER COIL PACKAGE, MODIFIED
2
Cleared 510(K)
K
90
3753
CAT. #6000-21 VOLUME NECK COIL, MODIFIED
2
Cleared 510(K)
K
90
2799
GYROSCAN S15/ACS
2
Cleared 510(K)
K
90
3822
MODEL 4500-SMS-42; SHOULDER COIL
2
Cleared 510(K)
K
90
3527
MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET
2
Cleared 510(K)
K
90
2217
TEMPOROMANDIBULAR JOINT (TMJ) COIL
2
Cleared 510(K)
K
90
2663
GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP
2
Cleared 510(K)
K
90
3203
MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION
2
Cleared 510(K)
K
90
3028
GYREX 2T VERSION 2.1U.
2
Cleared 510(K)
K
90
3204
MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL
2
Cleared 510(K)
K
90
3048
VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
90
2933
TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)
2
Cleared 510(K)
K
90
2044
MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
90
3319
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
90
1952
MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL
2
Cleared 510(K)
K
90
1888
PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15
2
Cleared 510(K)
K
90
2314
LARGE FLEXIBLE BODY COIL
2
Cleared 510(K)
K
90
2310
SOFTWARE RELEASE 4.2P, ACCESS(TM)
2
Cleared 510(K)
K
90
2315
CERVICAL COIL MRT 50A
2
Cleared 510(K)
K
90
2316
KNEE QD COIL MRT 50A
2
Cleared 510(K)
K
90
2630
BILATERAL TMJ COIL
2
Cleared 510(K)
K
90
1730
GE SIGNA ADVANTAGE
2
Cleared 510(K)
K
90
1980
MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
90
1864
MODEL 4050-21; 5.25 LOOP SHOULDER COIL
2
Cleared 510(K)
K
90
1818
ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63
2
Cleared 510(K)
K
90
1639
MODEL 4050-64; 5.25 & 4065-64; 6.50 LOOP COIL
2
Cleared 510(K)
K
90
0919
MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS
2
Cleared 510(K)
K
90
1602
VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
2
Cleared 510(K)
K
90
1620
MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI
2
Cleared 510(K)
K
90
0026
BRUKER R28 WHOLE-BODY MR SCANNER
2
Cleared 510(K)
K
90
1384
MODEL 6000-21; VOLUME NECK COIL
2
Cleared 510(K)
K
90
1305
MODEL 2121-21, TMJ SURFACE COIL
2
Cleared 510(K)
K
90
1242
MODEL 2121-64; TMJ SURFACE COIL
2
Cleared 510(K)
K
90
1241
THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64
2
Cleared 510(K)
K
90
1092
MODEL 8010; EXTREMITY SURFACE COIL
2
Cleared 510(K)
K
90
0889
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
2
Cleared 510(K)
K
90
0725
RADIO FREQUENCY RECEIVER SUBSYSTEM
2
Cleared 510(K)
K
90
0283
MRT 50A SOFTWARE RELEASE 9.0
2
Cleared 510(K)
K
90
0727
MRT 50A JOINT COIL
2
Cleared 510(K)
K
90
0728
MRT 50A KNEE COIL
2
Cleared 510(K)
K
90
0288
MRT 50A BRAIN QD COIL
2
Cleared 510(K)
K
90
0284
MRT 50A 150MM CIRCULAR SURFACE COIL
2
Cleared 510(K)
K
90
0285
MRT 50A FLEXIBLE BODY COIL
2
Cleared 510(K)
K
90
0289
MRT 50A 100MM CIRCULAR SURFACE COIL
2
Cleared 510(K)
K
90
0064
VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
89
5328
MAGNETIC RESONANCE SYSTEM MODEL BMT-1100
2
Cleared 510(K)
K
90
0287
MRT 50A CRANIO-CERVICAL COIL
2
Cleared 510(K)
K
90
0286
MRT 50A SPINE SURFACE COIL
2
Cleared 510(K)
K
89
6419
MODEL: GYREX VERSION V
2
Cleared 510(K)
K
89
5629
MODEL 8100; UPPER EXTREMITY COIL
2
Cleared 510(K)
K
89
6789
MODEL 6000; VOLUME NECK COIL
2
Cleared 510(K)
K
89
6508
VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
89
6309
MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC
2
Cleared 510(K)
K
89
4855
MODEL 5070; DUAL PLANAR PAIR
2
Cleared 510(K)
K
89
6336
MODEL SPINE SURVEYOR-PLUS; CAT. #ACS-10A
2
Cleared 510(K)
K
89
6647
GYROVIEW HR HIGH RESOLUTION WORKSTATION
2
Cleared 510(K)
K
89
5869
GYROSCAN T5 MOBILE
2
Cleared 510(K)
K
89
5966
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
2
Cleared 510(K)
K
89
4016
MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20
2
Cleared 510(K)
K
89
5794
GE MR MAX SYSTEM
2
Cleared 510(K)
K
89
4714
1989 SOFTWARE REVISION TO THE BMT-1100
2
Cleared 510(K)
K
89
3744
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
89
5151
VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
89
5131
MODEL 2031 TMJ SURFACE COIL
2
Cleared 510(K)
K
89
3518
MT/S SOFTWARE RELEASE 5.0.
2
Cleared 510(K)
K
89
5221
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
2
Cleared 510(K)
K
89
4974
MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
89
4290
ACCESS TM
2
Cleared 510(K)
K
89
3509
GE SIGNA ADVANTAGE
2
Cleared 510(K)
K
89
3750
MRT-50A MOBILE
2
Cleared 510(K)
K
89
3640
SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
2
Cleared 510(K)
K
89
3689
VISION INTEGRATED PERFORMANCE OPTION
2
Cleared 510(K)
K
89
3739
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
2
Cleared 510(K)
K
89
3675
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
2
Cleared 510(K)
K
89
3881
ACCESS TM
2
Cleared 510(K)
K
89
3619
VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
89
1760
MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED
2
Cleared 510(K)
K
89
1543
MAGNAVIEW MOBILE MRI VERSION 110 FHM
2
Cleared 510(K)
K
89
0092
HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
89
1769
MAGNISCAN 5000 MR SYSTEM
2
Cleared 510(K)
K
89
2959
VERSION 4.2 APPLICATION SOFTWARE
2
Cleared 510(K)
K
89
2235
GE SHOULDER SURFACE COIL, CAT. #M1085AN
2
Cleared 510(K)
K
89
1598
MODEL 2030; 3 TMJ SURFACE COIL
2
Cleared 510(K)
K
89
1541
MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.
2
Cleared 510(K)
K
89
0855
MODEL 4041; 4 ANGLED PAIR CRC SURFACE COIL
2
Cleared 510(K)
K
89
0789
GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
89
0666
MODEL 3031; CERVICAL SPINE SURFACE COIL
2
Cleared 510(K)
K
89
0815
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
2
Cleared 510(K)
K
89
0394
MEDRAD SCPD 1000
2
Cleared 510(K)
K
88
5047
VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
88
5223
RMI SHORT DISTANCE ALIGNMENT DEVICE
2
Cleared 510(K)
K
88
4816
ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY
2
Cleared 510(K)
K
88
3898
MAGNETOM 42 SP AND MAGNETOM 63 SP
2
Cleared 510(K)
K
88
4484
MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
2
Cleared 510(K)
K
88
4607
MT/S (SOFTWARE RELEASE 3.1)
2
Cleared 510(K)
K
88
4743
TEMPOROMANDIBULAR JOINT COIL (TMJ)
2
Cleared 510(K)
K
88
4606
MT/S (SPINE TRANSMIT COIL)
2
Cleared 510(K)
K
88
4603
SHOULDER TRANSMIT AND RECEIVE COILS
2
Cleared 510(K)
K
88
4604
MT/S CARLSON SPINE COIL, PART # 100-50082500-01
2
Cleared 510(K)
K
88
3547
GE MR MAX SYSTEM
2
Cleared 510(K)
K
88
4369
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
2
Cleared 510(K)
K
88
4062
MAGNETOM (M, H, 42, 63) SEQUENCES
2
Cleared 510(K)
K
88
3994
VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
88
3872
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
2
Cleared 510(K)
K
88
3756
TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM
2
Cleared 510(K)
K
88
3621
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
2
Cleared 510(K)
K
88
3699
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
2
Cleared 510(K)
K
88
3648
BETA 3000M MOBILE NMR IMAGING SYSTEM
2
Cleared 510(K)
K
88
3649
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
2
Cleared 510(K)
K
88
3519
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
2
Cleared 510(K)
K
88
3482
VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
88
3737
VFQ HEAD COIL
2
Cleared 510(K)
K
88
3520
0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST
2
Cleared 510(K)
K
88
3516
DIASONICS MT/P IMAGING SYSTEM
2
Cleared 510(K)
K
88
3378
VISTA MR 2055 HP SYSTEM
2
Cleared 510(K)
K
88
3650
INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110
2
Cleared 510(K)
K
88
3622
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
2
Cleared 510(K)
K
88
3521
C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS
2
Cleared 510(K)
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
86
0062
RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
86
0010
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
2
PMA Approval
P
86
0062
RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
84
0063
GYROSCAN(TM)
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
84
0063
GYROSCAN(TM)
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
84
0007
GYREX
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
85
0043
MAGNISCAN 5000 MRI SYSTEM
2
PMA Approval
P
85
0043
MAGNISCAN 5000 MRI SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
84
0007
GYREX, MODELS S3500 & S5000
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
84
0063
GYROSCAN(TM)
2
PMA Approval
P
84
0063
GYROSCAN(TM)
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
86
0010
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
86
0010
ACUTSCAN MODEL 100 MRI SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
84
0063
GYROSCAN(TM)
2
PMA Approval
P
84
0007
GYREX, MODELS S3500 & S5000
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
84
0063
GYROSCAN(TM)
2
PMA Approval
P
84
0063
GYROSCAN(TM)
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0052
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0074
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0076
FONAR NMR WHOLE BODY SCANNER BETA 3000
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0081
MAGNETOM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0051
TESLACON(TM) NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS NMR IMAGING SYSTEM
2
PMA Approval
P
83
0053
DIASONICS MT/S (MAGNETIC TOMOGRAPHY/SUPERCONDUCTIN
2
PMA Approval
LNI
System, Nuclear Magnetic Resonance Spectroscopic
2
Product Code
LQA
Media, Reusable Image
1
Product Code
MOS
Coil, Magnetic Resonance, Specialty
2
Product Code
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
2
Product Code
MUA
Bone Sonometer
2
Product Code
MUE
Full Field Digital, System, X-Ray, Mammographic
2
Product Code
MUI
Media, Coupling, Ultrasound
2
Product Code
MWP
Cabinet, X-Ray System
2
Product Code
MYN
Analyzer, Medical Image
2
Product Code
NCS
System, Imaging, Holography, Acoustic
2
Product Code
NWE
Colon Computed Tomography System, Computer Aided Detection
2
Product Code
OAS
X-Ray, Tomography, Computed, Dental
2
Product Code
OEB
Lung Computed Tomography System, Computer-Aided Detection
2
Product Code
OII
Arthrogram Tray
2
Product Code
OIJ
Biopsy Needle Guide Kit
2
Product Code
OIK
Radiology Dental Tray
2
Product Code
OIL
Discography Kit
2
Product Code
OIM
Mri Disposable Kit
2
Product Code
OIO
Radiographic Contrast Tray
2
Product Code
OIP
Radiology-Diagnostic Kit
2
Product Code
OMJ
Chest X-Ray Computer Aided Detection
2
Product Code
OQQ
Diagnostic Ultrasonic Transducer, Robotic
2
Product Code
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
2
Product Code
OWB
Interventional Fluoroscopic X-Ray System
2
Product Code
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
2
Product Code
PGY
Display, Diagnostic Radiology
2
Product Code
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
2
Product Code
QAS
Radiological Computer-Assisted Triage And Notification Software
2
Product Code
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
2
Product Code
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
2
Product Code
QHX
Fluoroscopic X-Ray Image Intensifier
1
Product Code
QHY
Solid State Fluoroscopic X-Ray Imager
2
Product Code
QIH
Automated Radiological Image Processing Software
2
Product Code
QKB
Radiological Image Processing Software For Radiation Therapy
2
Product Code
RCC
C-Arm Fluoroscopic X-Ray System
2
Product Code
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
2
Product Code
QXL
Cabinet, Emission Computed Tomography System
2
Product Code
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
LNH
/
K011418
View Source
ULTRAGUIDE MR-GUIDE 3000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011418
510(k) Type
Traditional
Applicant
ULTRAGUIDE LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2001
Days to Decision
15 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
EAG
Cephalometer
EAH
Cone, Radiographic, Lead-Lined
EAP
Unit, X-Ray, Intraoral
EHB
Collimator, X-Ray
EHD
Unit, X-Ray, Extraoral With Timer
MUH
System, X-Ray, Extraoral Source, Digital
EAM
Screen, Intensifying, Radiographic
EGT
Controller, Temperature, Radiographic
EGW
Dryer, Film, Radiographic
EGY
Processor, Radiographic-Film, Automatic, Dental
HBK
Chair, Pneumoencephalographic
ITX
Transducer, Ultrasonic, Diagnostic
ITY
Assembly, Tube Housing, X-Ray, Diagnostic
IWN
Cassette, Measurement, Ardran-Crooks
IWY
Holder, Head, Radiographic
IWZ
Film, Radiographic
IXA
Cassette, Radiographic Film
IXC
Illuminator, Radiographic-Film
IXD
Source, Calibration, Sealed, Nuclear
IXF
Test-Pattern, Radiographic
IXG
Phantom, Anthropomorphic, Radiographic
IXH
Camera, Focal Spot, Radiographic
IXJ
Grid, Radiographic
IXK
System, Imaging, X-Ray, Electrostatic
IXL
Device, Spot-Film
IXO
Synchronizer, Ecg / Respirator, Radiographic
IXQ
Table, Radiographic, Stationary Top
IXR
Table, Radiographic, Tilting
IXW
Processor, Radiographic-Film, Automatic
IXX
Processor, Cine Film
IXY
Holder, Radiographic Cassette, Wall-Mounted
IYB
Tube Mount, X-Ray, Diagnostic
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
IYO
System, Imaging, Pulsed Echo, Ultrasonic
IYP
Phantom, Anthropomorphic, Nuclear
IYQ
Phantom, Flood Source, Nuclear
IYT
System, Rebreathing, Radionuclide
IYW
Scanner, Rectilinear, Nuclear
IYX
Camera, Scintillation (Gamma)
IYY
Synchronizer, Electrocardiograph, Nuclear
IYZ
Bed, Scanning, Nuclear
IZC
Camera, Positron
IZD
Probe, Uptake, Nuclear
IZF
System, X-Ray, Tomographic
IZG
System, X-Ray, Photofluorographic
IZH
System, X-Ray, Mammographic
IZI
System, X-Ray, Angiographic
IZJ
Camera, X-Ray, Fluorographic, Cine Or Spot
IZL
System, X-Ray, Mobile
IZO
Generator, High-Voltage, X-Ray, Diagnostic
IZP
Programmer, Changer, Film/Cassette, Radiographic
IZS
Aperture, Radiographic
IZT
Cone, Radiographic
IZW
Collimator, Automatic, Radiographic
IZX
Collimator, Manual, Radiographic
IZZ
Table, Radiographic, Non-Tilting, Powered
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
JAB
System, X-Ray, Fluoroscopic, Non-Image-Intensified
JAC
System, X-Ray, Film Marking, Radiographic
JAF
Monitor, Ultrasonic, Nonfetal
JAG
Illuminator, Radiographic-Film, Explosion-Proof
JAK
System, X-Ray, Tomography, Computed
JAM
Scanner, Whole Body, Nuclear
JAN
Counter, Whole Body, Nuclear
JAO
Scanner, Fluorescent
JAR
Phantom, Test-Pattern, Radionuclide
JWM
System, Tomographic, Nuclear
KGI
Densitometer, Bone
KPR
System, X-Ray, Stationary
KPS
System, Tomography, Computed, Emission
KPT
Calibrator, Dose, Radionuclide
KPW
Device, Beam Limiting, X-Ray, Diagnostic
KPX
Changer, Radiographic Film/Cassette
KXH
Cradle, Patient, Radiologic
KXJ
Table, Radiologic
LEK
Transilluminator (Diaphanoscope)
LHO
Instrument, Quality-Assurance, Radiologic
LLZ
System, Image Processing, Radiological
LMA
Digitizer, Image, Radiological
LMB
Device, Digital Image Storage, Radiological
LMC
Camera, Multi Format, Radiological
LMD
System, Digital Image Communications, Radiological
LNH
System, Nuclear Magnetic Resonance Imaging
K
24
1242
SIGNA MAGNUS
K
24
1925
VitruvianScan (v1.0)
K
24
1331
MuscleView
K
24
1607
MyoStrain (6.0)
K
24
1496
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
K
24
1429
ECHELON Synergy MRI System
K
23
1133
neo315
K
24
0944
Swoop® Portable MR Imaging® System
K
24
1133
Magnifico Open (100009900); Magnifico MSK ( 100009910)
K
23
3629
APERTO Lucent MRI System
K
23
3687
ECHELON Synergy V10.0
K
23
3673
uMR Jupiter
K
24
0571
OASIS MRI System
K
24
0238
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
K
24
0744
uMR 680
K
24
0608
MAGNETOM Viato.Mobile
K
23
3733
SyMRI
K
24
0540
uMR Omega
K
23
2322
MAGNETOM Terra; MAGNETOM Terra.X
K
23
2765
MAGNETOM Cima.X Fit
K
24
0157
InVision™ 1.5 Surgical Theatre
K
23
2644
neuro42 MRI System
K
23
3728
SIGNA Champion
K
23
2535
MAGNETOM Sola; MAGNETOM Altea
K
23
1587
MAGNETOM Cima.X
K
23
2680
fMRI Hardware System
K
23
2494
MAGNETOM Avanto fit; MAGNETOM Skyra fit
K
23
1617
MAGNETOM Free.Max; MAGNETOM Free.Star
K
23
2346
Digital Expert Access with Remote Scanning
K
23
1560
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
K
23
2981
Synq Software Version 1.3
K
23
2760
Swoop® Portable MR Imaging System®
K
23
0187
Terran NM-101
K
23
2482
MAGNETOM Viato.Mobile
K
23
2361
Promaxo MRI System II
K
23
0355
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
K
23
2030
Ingenia Elition R5.7.1 SP4 MR Systems
K
22
3426
ECHELON Synergy MRI system
K
23
1459
HepaFatSmart (V2.0.0)
K
22
3523
Sonic DL
K
23
0152
uMR Omega
K
23
0758
uMR 570
K
23
0972
Ingenia Elition and MR 7700 MR Systems
K
22
3458
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
K
22
3343
MAGNETOM Amira; MAGNETOM Sempra
K
22
3875
MOBINEURO Alita Intraoperative MRI System
K
22
3203
1.5T 24E Posterior Array
K
21
3805
MAGNETOM Vida
K
23
0208
Swoop® Portable MR Imaging System™
K
22
2259
NEONA 1.5T MRI System
K
22
2755
uMR 680
K
22
3439
SIGNA Victor
K
22
1619
ECHELON Oval V6.2 MRI System
K
22
3442
MR 5300 and MR 7700 R11 MR Systems
K
22
3247
Swoop Portable MR Imaging System
K
22
3079
Stage
K
22
0332
uMR Omega with uWS-MR-MRS
K
22
2968
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
K
22
1733
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
K
21
3960
LiverMultiScan v5 (LMSv5)
K
22
2387
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K
22
1785
TCL3 Motion Tracking System
K
22
1923
Swoop Portable MR Imaging System
K
20
3279
Veuron-Brain-mN1
K
22
1025
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
K
22
0575
MAGNETOM Free.Max, MAGNETOM Free.Star
K
22
1393
Swoop Portable MR Imaging System
K
21
3717
AIR Recon DL
K
21
3583
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
K
22
0589
MAGNETOM Skyra Fit
K
22
0939
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
K
22
0192
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K
22
0335
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
K
22
0151
MAGNETOM Avanto Fit
K
22
0425
MAGNETOM Vida, MAGNETOM Sola
K
22
0018
MR Elastography; MZEK-001A
K
21
3516
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
K
21
3693
MAGNETOM Vida with syngo MR XA50A
K
21
3603
SIGNA Artist Evo
K
21
2419
Magnifico Open, Magnifico MSK
K
21
2271
smart-sync
K
21
3668
SIGNA Hero
K
21
1980
SIGNA Prime
K
21
3305
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
K
21
1983
AMRA Profiler
K
21
2673
MR 5300
K
21
2456
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K
20
3372
SyMRI
K
21
1406
OASIS MRI System
K
21
2233
RTHawk, HeartVista Cardiac Package
K
21
2367
IMRIS iMRI 3T V
K
21
2056
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K
21
1633
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
K
21
0415
QSM software, QSMetric
K
21
1818
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K
21
0611
MAGNETOM Free.Max
K
21
0843
STAGE
K
21
1037
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K
21
1118
SIGNA 7.0T
K
20
3451
TCL3 Motion Tracking System
K
21
0340
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
K
20
3443
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
K
21
0164
Vantage Elan 1.5T, MRT-2020, V6.0
K
20
3323
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K
20
2518
Promaxo MRI System
K
20
3653
MRI PPG Patient Cable
K
20
3553
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K
19
2650
i_Space 1.5T Superconducting Magnetic Resonance Imaging System
K
20
2767
Vantage Orian 1.5T, MRT-1550, V6.0
K
20
3280
Hepatica v1 (Hepatica v1.0.0)
K
20
1039
HepaFat-AI
K
20
3053
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
K
20
2966
SIGNA Architect
K
20
2030
OASIS MRI System
K
20
1615
SIGNA 7.0T
K
20
2170
LiverMultiScan
K
20
2210
Vantage Orian 1.5T, MRT-1550, V6.0
K
20
2014
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
K
20
2238
SIGNA Artist
K
20
1141
FIRMM
K
20
1722
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K
20
1616
SyMRI
K
19
3097
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
K
20
1389
Resoundant Acoustic Driver System
K
20
1540
uMR570
K
19
3021
Vantage Orian 1.5T, MRT-1550, V6.0