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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
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
Review Panel
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
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
K
24
0465
O-arm O2 Imaging System
2
Cleared 510(K)
K
23
3230
See Factor CT3™
2
Cleared 510(K)
K
24
0224
Zenition 90
2
Cleared 510(K)
K
24
0199
IntraOp Alignment System
2
Cleared 510(K)
K
23
2298
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
2
Cleared 510(K)
K
23
3748
CIARTIC Move (VB10)
2
Cleared 510(K)
K
23
2420
Zenition 30
2
Cleared 510(K)
K
24
0099
Ziehm Vision RFD
2
Cleared 510(K)
K
24
0020
Ziehm Vision FD
2
Cleared 510(K)
K
23
4109
Ziehm Solo FD
2
Cleared 510(K)
K
23
1700
Ziehm Vision FD
2
Cleared 510(K)
K
23
0949
ARTIS pheno (VE30A)
2
Cleared 510(K)
K
23
0950
ARTIS icono (VE30A)
2
Cleared 510(K)
K
23
1669
Ziehm Solo FD
2
Cleared 510(K)
K
23
1692
Ziehm Vision RFD
2
Cleared 510(K)
K
23
3200
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
2
Cleared 510(K)
K
23
2344
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
2
Cleared 510(K)
K
23
0871
EXTRON 5; EXTRON 7
2
Cleared 510(K)
K
23
0787
Oscar 15 & Oscar 15i
2
Cleared 510(K)
K
23
1701
Ziehm Vision RFD 3D
2
Cleared 510(K)
K
22
2998
F3
2
Cleared 510(K)
K
23
0185
ANT-X System
2
Cleared 510(K)
K
22
1344
nView s1 with nav option
2
Cleared 510(K)
K
22
3410
Cios Select (VA21) Flat Panel
2
Cleared 510(K)
K
22
3409
Cios Select (VA21) Image Intensifier
2
Cleared 510(K)
K
21
3768
Bolt Navigation System
2
Cleared 510(K)
K
22
1281
Multitom Rax
2
Cleared 510(K)
K
22
2070
EndoNaut
2
Cleared 510(K)
K
22
2080
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
2
Cleared 510(K)
K
22
2625
Shield System
2
Cleared 510(K)
K
22
0342
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
2
Cleared 510(K)
K
22
1922
Trinias
2
Cleared 510(K)
K
22
1230
TRON
2
Cleared 510(K)
K
22
1516
ARTIS icono (Ceiling Configuration)
2
Cleared 510(K)
K
22
0432
ARTIS icono (VE21) System
2
Cleared 510(K)
K
22
0409
ARTIS pheno (VE21) System
2
Cleared 510(K)
K
22
1335
D²RS and D²RS 9090
2
Cleared 510(K)
K
22
0311
Cardiovascular Angiography System
2
Cleared 510(K)
K
22
0946
SURGIVISIO Device
2
Cleared 510(K)
K
21
2159
Shield System
2
Cleared 510(K)
K
22
0627
SURGIVISIO Device
2
Cleared 510(K)
K
21
1780
ZEN-2090 Turbo
2
Cleared 510(K)
K
21
2212
Multitom Rax with True2scale Body Scan Option
2
Cleared 510(K)
K
21
3479
D²RS and D²RS 9090
2
Cleared 510(K)
K
21
2442
Cydar EV (Series B) and Cydar EV Maps
2
Cleared 510(K)
K
21
3455
ControlRad Select Model Z
2
Cleared 510(K)
K
21
2336
Soteria.AI
2
Cleared 510(K)
K
21
2956
FDR Cross (DR-XD 3000)
2
Cleared 510(K)
K
21
2523
VFSS Pro Mobile Digital Imaging System
2
Cleared 510(K)
K
21
1064
nView s1 with nav option
2
Cleared 510(K)
K
21
2813
Zenition 70
2
Cleared 510(K)
K
21
2557
Virtual C DRF-NEO Digital Imaging System
2
Cleared 510(K)
K
21
2383
EndoNaut
2
Cleared 510(K)
K
21
1777
ARCO FP-S
2
Cleared 510(K)
K
21
0912
Excelsius3D
2
Cleared 510(K)
K
21
1782
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
2
Cleared 510(K)
K
21
1191
Virtual C DRF Digital Imaging System
2
Cleared 510(K)
K
20
3535
Trinias
2
Cleared 510(K)
K
21
0900
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
2
Cleared 510(K)
K
20
3623
StentBoost Mobile
2
Cleared 510(K)
K
20
2547
Surgivisio system
2
Cleared 510(K)
K
21
0309
Cios Select (VA21) Flat Panel
2
Cleared 510(K)
K
21
0307
Cios Select (VA21) Image Intensifier
2
Cleared 510(K)
K
20
1743
ClarifEye R1.0, ClarifEye Needle
2
Cleared 510(K)
K
20
1583
SmartCT R1.0
2
Cleared 510(K)
K
21
0054
Cios Spin
2
Cleared 510(K)
K
21
0055
Cios Alpha
2
Cleared 510(K)
K
20
2431
ControlRad Select Model Z
2
Cleared 510(K)
K
20
3504
Cios Flow
2
Cleared 510(K)
K
20
3281
Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
2
Cleared 510(K)
K
20
3551
Alphenix, INFX-8000V/B, /S, V9.1
2
Cleared 510(K)
K
20
2360
Ziehm Vision RFD 3D
2
Cleared 510(K)
K
20
0218
Digiscan FDX
2
Cleared 510(K)
K
20
1156
ARTIS pheno (VE2)
2
Cleared 510(K)
K
20
0663
ControlRad Trace Model 9
2
Cleared 510(K)
K
20
1172
CFP-3131, CFP-2222
2
Cleared 510(K)
K
20
0917
Azurion R2.1
2
Cleared 510(K)
K
20
0074
O-arm O2 Imaging System
2
Cleared 510(K)
K
19
3326
ARTIS Icono
2
Cleared 510(K)
K
20
0887
AS-10
2
Cleared 510(K)
K
20
0022
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
2
Cleared 510(K)
K
20
0360
TrackX
2
Cleared 510(K)
K
19
2182
C015
2
Cleared 510(K)
K
19
3230
Ziehm Vision FD
2
Cleared 510(K)
K
18
3144
uMC 560i
2
Cleared 510(K)
K
19
0497
Ziehm 8000
2
Cleared 510(K)
K
19
0768
ARTIS icono
2
Cleared 510(K)
K
19
1503
MobileRay Pulse SE Digital Imaging System
2
Cleared 510(K)
K
18
2086
ARCO FP
2
Cleared 510(K)
K
19
0064
nView system 1
2
Cleared 510(K)
K
18
3109
ControlRad Trace Model 8
2
Cleared 510(K)
K
19
0626
SyncVision System
2
Cleared 510(K)
K
18
3101
Zenition 50
2
Cleared 510(K)
K
18
3040
Zenition 70
2
Cleared 510(K)
K
18
1403
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
2
Cleared 510(K)
K
18
1550
Cios Spin
2
Cleared 510(K)
K
18
1560
Cios Alpha
2
Cleared 510(K)
K
18
2546
Alphenix, INFX-8000H/B, V8.0
2
Cleared 510(K)
K
18
2415
Alphenix, INFX-8000F/B, V8.0
2
Cleared 510(K)
K
18
1415
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
2
Cleared 510(K)
K
18
1966
SmartPerfusion
2
Cleared 510(K)
K
18
1943
OSCAR (OSCAR Prime, OSCAR Classic)
2
Cleared 510(K)
K
18
1767
Cios Select
2
Cleared 510(K)
K
18
1407
Artis zee/zeego & Artis Q/Q.zen
2
Cleared 510(K)
K
18
1830
Azurion R2.0
2
Cleared 510(K)
K
18
1804
Alphenix, INFX-8000C/B, V8.0
2
Cleared 510(K)
K
18
1670
Alphenix, INFX-8000V/B, V8.0
2
Cleared 510(K)
K
18
1834
Ultimax-i, DREX-UI80 (V1.60)
2
Cleared 510(K)
K
17
3631
Intelli-C
2
Cleared 510(K)
K
17
3639
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
2
Cleared 510(K)
K
18
0473
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
2
Cleared 510(K)
K
17
3736
TrackX
2
Cleared 510(K)
K
17
2180
OSCAR 15
2
Cleared 510(K)
K
17
1755
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
2
Cleared 510(K)
K
17
3433
ProxiDiagnost N90
2
Cleared 510(K)
K
17
3664
Medtronic O-arm O2 Imaging System
2
Cleared 510(K)
K
17
2863
Infinix-i, INFX-8000V, V7.0
2
Cleared 510(K)
K
17
2822
Azurion series R1.2
2
Cleared 510(K)
K
17
3314
LessRay System
2
Cleared 510(K)
K
17
2700
OEC One
2
Cleared 510(K)
K
17
2646
XIDF-AWS801, Angio Workstation, V7.0
2
Cleared 510(K)
K
17
2307
Dynamic Coronary Roadmap 2.0
2
Cleared 510(K)
K
17
2574
SyncVision System
2
Cleared 510(K)
K
17
1829
EndoNaut
2
Cleared 510(K)
K
17
0800
NuVasive LessRay with Enhanced Tracking
2
Cleared 510(K)
K
17
1565
OEC Elite
2
Cleared 510(K)
K
17
0832
Ultimax-i, DREX-UI80 V1.60
2
Cleared 510(K)
K
17
0909
Infinix INFX-8000V, V6.40
2
Cleared 510(K)
K
17
0144
StentBoost Live
2
Cleared 510(K)
K
17
0130
Dynamic Coronary Roadmap
2
Cleared 510(K)
K
16
3140
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
2
Cleared 510(K)
K
17
1194
AS-10, CXDI-401RF
2
Cleared 510(K)
K
17
0752
OEC Elite
2
Cleared 510(K)
K
16
3286
ARTIS pheno
2
Cleared 510(K)
K
16
3715
Allura Xper R9
2
Cleared 510(K)
K
16
2859
Allura Xper FD series and Allura Xper OR Table series
2
Cleared 510(K)
K
16
2148
Allura Xper R9
2
Cleared 510(K)
K
16
2614
Infinix, INFX-8000V, V6.35
2
Cleared 510(K)
K
16
0279
ANYVIEW-500R Fluoroscopic Mobile X-Ray System
2
Cleared 510(K)
K
16
1976
Ziehm Solo FD
2
Cleared 510(K)
K
16
1756
SyncVision System
2
Cleared 510(K)
K
16
0455
AneurysmFlow
2
Cleared 510(K)
K
16
0147
CT TrueView
2
Cleared 510(K)
K
16
1839
2D Quantitative Analysis
2
Cleared 510(K)
K
16
1563
Allura Xper FD series and Allura Xper OR Table series
2
Cleared 510(K)
K
16
0088
Cydar EV
2
Cleared 510(K)
K
15
3244
Cios Fusion
2
Cleared 510(K)
K
15
3232
Cios Select
2
Cleared 510(K)
K
15
2697
INFX-8000C, V6.20
2
Cleared 510(K)
K
15
3147
Cios Connect
2
Cleared 510(K)
K
15
2696
INFX-8000V, V6.20
2
Cleared 510(K)
K
15
2785
XIDF-AWS801, Angio Workstation, V6.20
2
Cleared 510(K)
K
15
2928
Multitom Rax
2
Cleared 510(K)
K
15
1598
VesselNavigator Rel. 1.0
2
Cleared 510(K)
K
15
1000
O-Arm O2 Imaging System
2
Cleared 510(K)
K
15
1904
SyncVision System
2
Cleared 510(K)
K
15
0967
XIDF-AWS801, Angio Workstation, V6.10
2
Cleared 510(K)
K
14
2740
Ziehm Vision RFD 3D
2
Cleared 510(K)
K
14
2736
XIDF-AWS801, Angio Workstation, v5.31
2
Cleared 510(K)
K
14
2273
EmboGuide
2
Cleared 510(K)
K
14
3281
Ultimax-i
2
Cleared 510(K)
K
14
3225
INFX-8000V with Wireless Footswitch
2
Cleared 510(K)
K
14
2126
EP NAVIGATOR REL. 5.0
2
Cleared 510(K)
K
14
0041
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
2
Cleared 510(K)
K
14
2243
LessRay with Tracking
2
Cleared 510(K)
K
14
2708
VERADIUS UNITY
2
Cleared 510(K)
K
14
1574
ARTIS ZEE/ZEEGO SW VC21
2
Cleared 510(K)
K
14
1979
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
2
Cleared 510(K)
K
13
3535
INFX-8000V, V5.30
2
Cleared 510(K)
K
13
3819
VERADIUS
2
Cleared 510(K)
K
14
0138
HEARTNAVIGATOR RELEASE 2.0
2
Cleared 510(K)
K
13
2027
OEC 9800 PLUS
2
Cleared 510(K)
K
13
3580
ARTIS ONE
2
Cleared 510(K)
K
13
3278
DISCOVERY IGS 740
2
Cleared 510(K)
K
13
2094
CIOS ALPHA
2
Cleared 510(K)
K
13
3292
ALLURA XPER FD; OR TABLE
2
Cleared 510(K)
K
12
3508
TRINIAS
2
Cleared 510(K)
K
13
2147
2D PERFUSION
2
Cleared 510(K)
K
13
2558
SYNC-RX SYSTEM
2
Cleared 510(K)
K
13
2970
LESSRAY
2
Cleared 510(K)
K
13
2305
STENTBOOST REL. 4
2
Cleared 510(K)
K
13
0893
XPERCT REL. 3
2
Cleared 510(K)
K
13
1263
XPERGUIDE
2
Cleared 510(K)
K
13
0638
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
2
Cleared 510(K)
K
12
2644
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
2
Cleared 510(K)
K
12
1772
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
2
Cleared 510(K)
K
12
3529
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
2
Cleared 510(K)
K
12
2457
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
2
Cleared 510(K)
K
12
0282
CARDNAV
2
Cleared 510(K)
K
12
3226
LESSRAY
2
Cleared 510(K)
K
12
2234
OEC 9900 ELITE
2
Cleared 510(K)
K
12
1444
FLAT PANEL DETECTOR
2
Cleared 510(K)
K
11
3403
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
2
Cleared 510(K)
K
12
0073
INFX-8000V WITH
2
Cleared 510(K)
K
11
3027
SYNGO AORTIC VALVEGUIDE SOFTWARE
2
Cleared 510(K)
K
11
1551
OEC(R) 9800, OEC(R) 9800 PLUS
2
Cleared 510(K)
K
11
2180
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
2
Cleared 510(K)
K
11
1344
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
2
Cleared 510(K)
K
10
3425
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
2
Cleared 510(K)
K
10
3416
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
2
Cleared 510(K)
K
10
2529
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
2
Cleared 510(K)
K
10
1868
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
2
Cleared 510(K)
K
10
0102
CS-SERIES-FP
2
Cleared 510(K)
K
10
2005
ALLURA XPER OR TABLE SERIES
2
Cleared 510(K)
K
10
1833
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
2
Cleared 510(K)
K
09
3066
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
2
Cleared 510(K)
K
09
3688
CANON, MODEL URS-50RF
2
Cleared 510(K)
K
09
2438
ZIEHM SOLO
2
Cleared 510(K)
K
09
2439
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
2
Cleared 510(K)
K
09
1918
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
2
Cleared 510(K)
K
09
2004
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
2
Cleared 510(K)
K
09
1658
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121
2
Cleared 510(K)
K
08
3545
ZIEHM VISION RFD
2
Cleared 510(K)
K
08
2781
OEC 9900 ELITE
2
Cleared 510(K)
K
09
0590
VERADIUS, MODEL 718-130
2
Cleared 510(K)
K
08
3725
RADPRO ION
2
Cleared 510(K)
K
08
1073
HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
2
Cleared 510(K)
K
08
2243
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
2
Cleared 510(K)
K
08
0847
RFVISION, MODEL 9.9D
2
Cleared 510(K)
K
07
3543
OEC 9900 ELITE
2
Cleared 510(K)
K
06
2623
AXIOM LUMINOS DRF
2
Cleared 510(K)
K
07
0834
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
2
Cleared 510(K)
K
07
0123
TCA 5R / 5S
2
Cleared 510(K)
K
06
2647
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
2
Cleared 510(K)
K
06
1953
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
2
Cleared 510(K)
K
06
1534
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
2
Cleared 510(K)
K
06
1203
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
2
Cleared 510(K)
K
06
1173
CPIVISION DIGITAL IMAGING SYSTEM
2
Cleared 510(K)
K
06
1163
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
2
Cleared 510(K)
K
05
2202
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
2
Cleared 510(K)
K
06
0259
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
2
Cleared 510(K)
K
05
3279
UROVANTAGE
2
Cleared 510(K)
K
05
2884
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
2
Cleared 510(K)
K
05
2412
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
2
Cleared 510(K)
K
05
1064
ZIEHM QUANTUM
2
Cleared 510(K)
K
05
0489
INNOVA 2100
2
Cleared 510(K)
K
04
3076
GE OEC FLUOROSTAR
2
Cleared 510(K)
K
04
2793
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
2
Cleared 510(K)
K
04
2053
INNOVA 4100, INNOVA 3100
2
Cleared 510(K)
K
04
1931
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
2
Cleared 510(K)
K
04
1932
OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
2
Cleared 510(K)
K
04
1780
NEW BRID
2
Cleared 510(K)
K
04
1605
PRECISION RXI ANALOG X-RAY SYSTEM
2
Cleared 510(K)
K
04
0675
AXIOM ARTIS U
2
Cleared 510(K)
K
03
2761
KMC-950 C-ARM MOBILE SYSTEM
2
Cleared 510(K)
K
03
3737
ALLURA XPER FD20
2
Cleared 510(K)
K
03
3486
GE PRECISION MPI
2
Cleared 510(K)
K
03
3244
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
2
Cleared 510(K)
K
03
1637
INNOVA 3100
2
Cleared 510(K)
K
03
2046
PHILLIPS OMNIDIAGNOST ELEVA
2
Cleared 510(K)
K
03
0544
RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
2
Cleared 510(K)
K
03
0061
PS 3000 DIGATAL PHOTOSPOT SYSTEM
2
Cleared 510(K)
K
02
4200
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
2
Cleared 510(K)
K
02
3178
INNOVA 4100
2
Cleared 510(K)
K
02
2322
INNOVA AND INNOVA 2000 S
2
Cleared 510(K)
K
02
2114
IMPERIUM
2
Cleared 510(K)
K
02
2069
OEC FLUOROTRAK 9800 PLUS
2
Cleared 510(K)
K
02
1049
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
2
Cleared 510(K)
K
01
2490
ORION DIGITAL IMAGING SYSTEM
2
Cleared 510(K)
K
01
3608
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
2
Cleared 510(K)
K
01
1311
UROLOGIC
2
Cleared 510(K)
K
01
1292
ZIEHM VISION
2
Cleared 510(K)
K
01
0942
U04
2
Cleared 510(K)
K
01
0435
PHILIPS BV PULSERA/ENDURA
2
Cleared 510(K)
K
00
2198
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS
2
Cleared 510(K)
K
00
2016
PHILIPS INTEGRIS ALLURA
2
Cleared 510(K)
K
00
0221
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
2
Cleared 510(K)
K
99
3037
LCV+ VERSION 2
2
Cleared 510(K)
K
99
3687
UROVIEW 2800
2
Cleared 510(K)
K
99
2660
URF DIGITAL - OT
2
Cleared 510(K)
K
99
2103
C-QUEST
2
Cleared 510(K)
K
98
3069
PHILIPS DUO DIAGNOST
2
Cleared 510(K)
K
98
2993
PHILIPS OMNIDIAGNOST
2
Cleared 510(K)
K
98
2427
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
2
Cleared 510(K)
K
97
4355
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
2
Cleared 510(K)
K
97
0734
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
2
Cleared 510(K)
K
97
0063
SERIES 7600 MOBILE DIGITAL C-ARM
2
Cleared 510(K)
K
96
3952
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
2
Cleared 510(K)
K
96
1105
SKIN DOSE MONITOR
2
Cleared 510(K)
K
96
1374
PHILIPS MULTIDIAGNOST 4
2
Cleared 510(K)
K
96
0920
CLINIX MP
2
Cleared 510(K)
K
92
1219
PHILIPS DCI-SX
2
Cleared 510(K)
K
93
6180
TC+ SYSTEM (TILTING C-ARM SYSTEM)
2
Cleared 510(K)
K
92
3049
UROSKOP D1, UROSKOP D2, AND UROSKOP D3
2
Cleared 510(K)
K
91
2448
CSP
2
Cleared 510(K)
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 16 August 2024 at 11:05 pm
RA
/
subpart-b—diagnostic-devices
/
OWB
/
K123508
View Source
TRINIAS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123508
510(k) Type
Abbreviated
Applicant
Shimadzu Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
2/26/2014
Days to Decision
470 days
Submission Type
Statement
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
LNI
System, Nuclear Magnetic Resonance Spectroscopic
LQA
Media, Reusable Image
MOS
Coil, Magnetic Resonance, Specialty
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
MUA
Bone Sonometer
MUE
Full Field Digital, System, X-Ray, Mammographic
MUI
Media, Coupling, Ultrasound
MWP
Cabinet, X-Ray System
MYN
Analyzer, Medical Image
NCS
System, Imaging, Holography, Acoustic
NWE
Colon Computed Tomography System, Computer Aided Detection
OAS
X-Ray, Tomography, Computed, Dental
OEB
Lung Computed Tomography System, Computer-Aided Detection
OII
Arthrogram Tray
OIJ
Biopsy Needle Guide Kit
OIK
Radiology Dental Tray
OIL
Discography Kit
OIM
Mri Disposable Kit
OIO
Radiographic Contrast Tray
OIP
Radiology-Diagnostic Kit
OMJ
Chest X-Ray Computer Aided Detection
OQQ
Diagnostic Ultrasonic Transducer, Robotic
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OWB
Interventional Fluoroscopic X-Ray System
K
24
0465
O-arm O2 Imaging System
K
23
3230
See Factor CT3™
K
24
0224
Zenition 90
K
24
0199
IntraOp Alignment System
K
23
2298
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
K
23
3748
CIARTIC Move (VB10)
K
23
2420
Zenition 30
K
24
0099
Ziehm Vision RFD
K
24
0020
Ziehm Vision FD
K
23
4109
Ziehm Solo FD
K
23
1700
Ziehm Vision FD
K
23
0949
ARTIS pheno (VE30A)
K
23
0950
ARTIS icono (VE30A)
K
23
1669
Ziehm Solo FD
K
23
1692
Ziehm Vision RFD
K
23
3200
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
K
23
2344
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
K
23
0871
EXTRON 5; EXTRON 7
K
23
0787
Oscar 15 & Oscar 15i
K
23
1701
Ziehm Vision RFD 3D
K
22
2998
F3
K
23
0185
ANT-X System
K
22
1344
nView s1 with nav option
K
22
3410
Cios Select (VA21) Flat Panel
K
22
3409
Cios Select (VA21) Image Intensifier
K
21
3768
Bolt Navigation System
K
22
1281
Multitom Rax
K
22
2070
EndoNaut
K
22
2080
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
K
22
2625
Shield System
K
22
0342
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
K
22
1922
Trinias
K
22
1230
TRON
K
22
1516
ARTIS icono (Ceiling Configuration)
K
22
0432
ARTIS icono (VE21) System
K
22
0409
ARTIS pheno (VE21) System
K
22
1335
D²RS and D²RS 9090
K
22
0311
Cardiovascular Angiography System
K
22
0946
SURGIVISIO Device
K
21
2159
Shield System
K
22
0627
SURGIVISIO Device
K
21
1780
ZEN-2090 Turbo
K
21
2212
Multitom Rax with True2scale Body Scan Option
K
21
3479
D²RS and D²RS 9090
K
21
2442
Cydar EV (Series B) and Cydar EV Maps
K
21
3455
ControlRad Select Model Z
K
21
2336
Soteria.AI
K
21
2956
FDR Cross (DR-XD 3000)
K
21
2523
VFSS Pro Mobile Digital Imaging System
K
21
1064
nView s1 with nav option
K
21
2813
Zenition 70
K
21
2557
Virtual C DRF-NEO Digital Imaging System
K
21
2383
EndoNaut
K
21
1777
ARCO FP-S
K
21
0912
Excelsius3D
K
21
1782
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
K
21
1191
Virtual C DRF Digital Imaging System
K
20
3535
Trinias
K
21
0900
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
K
20
3623
StentBoost Mobile
K
20
2547
Surgivisio system
K
21
0309
Cios Select (VA21) Flat Panel
K
21
0307
Cios Select (VA21) Image Intensifier
K
20
1743
ClarifEye R1.0, ClarifEye Needle
K
20
1583
SmartCT R1.0
K
21
0054
Cios Spin
K
21
0055
Cios Alpha
K
20
2431
ControlRad Select Model Z
K
20
3504
Cios Flow
K
20
3281
Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
K
20
3551
Alphenix, INFX-8000V/B, /S, V9.1
K
20
2360
Ziehm Vision RFD 3D
K
20
0218
Digiscan FDX
K
20
1156
ARTIS pheno (VE2)
K
20
0663
ControlRad Trace Model 9
K
20
1172
CFP-3131, CFP-2222
K
20
0917
Azurion R2.1
K
20
0074
O-arm O2 Imaging System
K
19
3326
ARTIS Icono
K
20
0887
AS-10
K
20
0022
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
K
20
0360
TrackX
K
19
2182
C015
K
19
3230
Ziehm Vision FD
K
18
3144
uMC 560i
K
19
0497
Ziehm 8000
K
19
0768
ARTIS icono
K
19
1503
MobileRay Pulse SE Digital Imaging System
K
18
2086
ARCO FP
K
19
0064
nView system 1
K
18
3109
ControlRad Trace Model 8
K
19
0626
SyncVision System
K
18
3101
Zenition 50
K
18
3040
Zenition 70
K
18
1403
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
K
18
1550
Cios Spin
K
18
1560
Cios Alpha
K
18
2546
Alphenix, INFX-8000H/B, V8.0
K
18
2415
Alphenix, INFX-8000F/B, V8.0
K
18
1415
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
K
18
1966
SmartPerfusion
K
18
1943
OSCAR (OSCAR Prime, OSCAR Classic)
K
18
1767
Cios Select
K
18
1407
Artis zee/zeego & Artis Q/Q.zen
K
18
1830
Azurion R2.0
K
18
1804
Alphenix, INFX-8000C/B, V8.0
K
18
1670
Alphenix, INFX-8000V/B, V8.0
K
18
1834
Ultimax-i, DREX-UI80 (V1.60)
K
17
3631
Intelli-C
K
17
3639
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
K
18
0473
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
K
17
3736
TrackX
K
17
2180
OSCAR 15
K
17
1755
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
K
17
3433
ProxiDiagnost N90
K
17
3664
Medtronic O-arm O2 Imaging System
K
17
2863
Infinix-i, INFX-8000V, V7.0
K
17
2822
Azurion series R1.2
K
17
3314
LessRay System
K
17
2700
OEC One
K
17
2646
XIDF-AWS801, Angio Workstation, V7.0
K
17
2307
Dynamic Coronary Roadmap 2.0
K
17
2574
SyncVision System
K
17
1829
EndoNaut
K
17
0800
NuVasive LessRay with Enhanced Tracking
K
17
1565
OEC Elite
K
17
0832
Ultimax-i, DREX-UI80 V1.60
K
17
0909
Infinix INFX-8000V, V6.40
K
17
0144
StentBoost Live
K
17
0130
Dynamic Coronary Roadmap
K
16
3140
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
K
17
1194
AS-10, CXDI-401RF
K
17
0752
OEC Elite
K
16
3286
ARTIS pheno
K
16
3715
Allura Xper R9
K
16
2859
Allura Xper FD series and Allura Xper OR Table series
K
16
2148
Allura Xper R9
K
16
2614
Infinix, INFX-8000V, V6.35
K
16
0279
ANYVIEW-500R Fluoroscopic Mobile X-Ray System
K
16
1976
Ziehm Solo FD
K
16
1756
SyncVision System
K
16
0455
AneurysmFlow
K
16
0147
CT TrueView
K
16
1839
2D Quantitative Analysis
K
16
1563
Allura Xper FD series and Allura Xper OR Table series
K
16
0088
Cydar EV
K
15
3244
Cios Fusion
K
15
3232
Cios Select
K
15
2697
INFX-8000C, V6.20
K
15
3147
Cios Connect
K
15
2696
INFX-8000V, V6.20
K
15
2785
XIDF-AWS801, Angio Workstation, V6.20
K
15
2928
Multitom Rax
K
15
1598
VesselNavigator Rel. 1.0
K
15
1000
O-Arm O2 Imaging System
K
15
1904
SyncVision System
K
15
0967
XIDF-AWS801, Angio Workstation, V6.10
K
14
2740
Ziehm Vision RFD 3D
K
14
2736
XIDF-AWS801, Angio Workstation, v5.31
K
14
2273
EmboGuide
K
14
3281
Ultimax-i
K
14
3225
INFX-8000V with Wireless Footswitch
K
14
2126
EP NAVIGATOR REL. 5.0
K
14
0041
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
K
14
2243
LessRay with Tracking
K
14
2708
VERADIUS UNITY
K
14
1574
ARTIS ZEE/ZEEGO SW VC21
K
14
1979
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
K
13
3535
INFX-8000V, V5.30
K
13
3819
VERADIUS
K
14
0138
HEARTNAVIGATOR RELEASE 2.0
K
13
2027
OEC 9800 PLUS
K
13
3580
ARTIS ONE
K
13
3278
DISCOVERY IGS 740
K
13
2094
CIOS ALPHA
K
13
3292
ALLURA XPER FD; OR TABLE
K
12
3508
TRINIAS
K
13
2147
2D PERFUSION
K
13
2558
SYNC-RX SYSTEM
K
13
2970
LESSRAY
K
13
2305
STENTBOOST REL. 4
K
13
0893
XPERCT REL. 3
K
13
1263
XPERGUIDE
K
13
0638
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
K
12
2644
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
K
12
1772
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
K
12
3529
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
K
12
2457
GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
K
12
0282
CARDNAV
K
12
3226
LESSRAY
K
12
2234
OEC 9900 ELITE
K
12
1444
FLAT PANEL DETECTOR
K
11
3403
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
K
12
0073
INFX-8000V WITH
K
11
3027
SYNGO AORTIC VALVEGUIDE SOFTWARE
K
11
1551
OEC(R) 9800, OEC(R) 9800 PLUS
K
11
2180
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
K
11
1344
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
K
10
3425
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
K
10
3416
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
K
10
2529
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
K
10
1868
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
K
10
0102
CS-SERIES-FP
K
10
2005
ALLURA XPER OR TABLE SERIES
K
10
1833
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
K
09
3066
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
K
09
3688
CANON, MODEL URS-50RF
K
09
2438
ZIEHM SOLO
K
09
2439
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
K
09
1918
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
K
09
2004
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
K
09
1658
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121
K
08
3545
ZIEHM VISION RFD
K
08
2781
OEC 9900 ELITE
K
09
0590
VERADIUS, MODEL 718-130
K
08
3725
RADPRO ION
K
08
1073
HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
K
08
2243
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
K
08
0847
RFVISION, MODEL 9.9D
K
07
3543
OEC 9900 ELITE
K
06
2623
AXIOM LUMINOS DRF
K
07
0834
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
K
07
0123
TCA 5R / 5S
K
06
2647
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
K
06
1953
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
K
06
1534
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
K
06
1203
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
K
06
1173
CPIVISION DIGITAL IMAGING SYSTEM
K
06
1163
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
K
05
2202
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
K
06
0259
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
K
05
3279
UROVANTAGE
K
05
2884
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
K
05
2412
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K
05
1064
ZIEHM QUANTUM
K
05
0489
INNOVA 2100
K
04
3076
GE OEC FLUOROSTAR
K
04
2793
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
K
04
2053
INNOVA 4100, INNOVA 3100
K
04
1931
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
K
04
1932
OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
K
04
1780
NEW BRID
K
04
1605
PRECISION RXI ANALOG X-RAY SYSTEM
K
04
0675
AXIOM ARTIS U
K
03
2761
KMC-950 C-ARM MOBILE SYSTEM
K
03
3737
ALLURA XPER FD20
K
03
3486
GE PRECISION MPI
K
03
3244
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K
03
1637
INNOVA 3100
K
03
2046
PHILLIPS OMNIDIAGNOST ELEVA
K
03
0544
RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
K
03
0061
PS 3000 DIGATAL PHOTOSPOT SYSTEM
K
02
4200
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K
02
3178
INNOVA 4100
K
02
2322
INNOVA AND INNOVA 2000 S
K
02
2114
IMPERIUM
K
02
2069
OEC FLUOROTRAK 9800 PLUS
K
02
1049
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
K
01
2490
ORION DIGITAL IMAGING SYSTEM
K
01
3608
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K
01
1311
UROLOGIC
K
01
1292
ZIEHM VISION
K
01
0942
U04
K
01
0435
PHILIPS BV PULSERA/ENDURA
K
00
2198
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS
K
00
2016
PHILIPS INTEGRIS ALLURA
K
00
0221
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
K
99
3037
LCV+ VERSION 2
K
99
3687
UROVIEW 2800
K
99
2660
URF DIGITAL - OT
K
99
2103
C-QUEST
K
98
3069
PHILIPS DUO DIAGNOST
K
98
2993
PHILIPS OMNIDIAGNOST
K
98
2427
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
K
97
4355
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
K
97
0734
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
K
97
0063
SERIES 7600 MOBILE DIGITAL C-ARM
K
96
3952
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
K
96
1105
SKIN DOSE MONITOR
K
96
1374
PHILIPS MULTIDIAGNOST 4
K
96
0920
CLINIX MP
K
92
1219
PHILIPS DCI-SX
K
93
6180
TC+ SYSTEM (TILTING C-ARM SYSTEM)
K
92
3049
UROSKOP D1, UROSKOP D2, AND UROSKOP D3
K
91
2448
CSP
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
PGY
Display, Diagnostic Radiology
POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QAS
Radiological Computer-Assisted Triage And Notification Software
QFM
Radiological Computer-Assisted Prioritization Software For Lesions
QHA
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
QHX
Fluoroscopic X-Ray Image Intensifier
QHY
Solid State Fluoroscopic X-Ray Imager
QIH
Automated Radiological Image Processing Software
QKB
Radiological Image Processing Software For Radiation Therapy
RCC
C-Arm Fluoroscopic X-Ray System
QTZ
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
QXL
Cabinet, Emission Computed Tomography System
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-b—diagnostic-devices
/
OWB
/
K123508
View Source
TRINIAS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123508
510(k) Type
Abbreviated
Applicant
Shimadzu Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
2/26/2014
Days to Decision
470 days
Submission Type
Statement