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Ophthalmic
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Orthopedic
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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
LNI
System, Nuclear Magnetic Resonance Spectroscopic
2
Product Code
LQA
Media, Reusable Image
1
Product Code
MOS
Coil, Magnetic Resonance, Specialty
2
Product Code
K
24
3316
XENOVIEW 3.0T Chest Coil
2
Cleared 510(K)
K
24
3033
dS Wrist coil 8ch 1.5T
2
Cleared 510(K)
K
24
2879
dS Knee Coil 8ch 1.5T
2
Cleared 510(K)
K
24
2096
dS FootAnkle Coil 8ch 1.5T
2
Cleared 510(K)
K
24
1069
iLoop Interventional Coil 0.55T
2
Cleared 510(K)
K
23
3652
Contour Hand/Wrist (Q7000232)
2
Cleared 510(K)
K
23
3656
Contour Shoulder
2
Cleared 510(K)
K
23
3600
Smart Fit Knee 3.0T
2
Cleared 510(K)
K
23
3444
InkSpace Imaging Small Body Array
2
Cleared 510(K)
K
23
3348
16 Breast Coil
2
Cleared 510(K)
K
23
2762
dS Breast Coil 7ch 1.5T
2
Cleared 510(K)
K
23
2021
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
2
Cleared 510(K)
K
23
1085
1.5T HD T/R Knee Array (10-F34127)
2
Cleared 510(K)
K
22
3484
IGAR System (1001.A)
2
Cleared 510(K)
K
23
1647
XENOVIEW 3.0T Chest Coil
2
Cleared 510(K)
K
22
3225
8ch T/R Knee Coil
2
Cleared 510(K)
K
21
3480
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
2
Cleared 510(K)
K
22
3429
Contour Knee
2
Cleared 510(K)
K
22
3378
3.0T 16ch AIR AA
2
Cleared 510(K)
K
21
2239
XENOVIEW 3.0T Chest Coil
2
Cleared 510(K)
K
22
3487
InkSpace Imaging Body Array
2
Cleared 510(K)
K
22
3239
8ch Wrist Coil
2
Cleared 510(K)
K
22
2407
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
2
Cleared 510(K)
K
22
2325
8ch Wrist Coil
2
Cleared 510(K)
K
22
2257
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
2
Cleared 510(K)
K
21
3735
dS Sentinelle Breast 16ch 1.5T Coil
2
Cleared 510(K)
K
21
3727
dS Sentinelle Breast 16ch 3.0T Coil
2
Cleared 510(K)
K
22
0144
Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
2
Cleared 510(K)
K
21
3687
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
2
Cleared 510(K)
K
21
1658
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
2
Cleared 510(K)
K
21
3766
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
2
Cleared 510(K)
K
21
3397
InkSpace Imaging Pediatric Body Array
2
Cleared 510(K)
K
21
2864
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
2
Cleared 510(K)
K
21
3351
ds Head 32ch 3.0T
2
Cleared 510(K)
K
20
0836
8ch Flex Suite
2
Cleared 510(K)
K
20
1101
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
2
Cleared 510(K)
K
20
0477
Flex Body Speeder
2
Cleared 510(K)
K
19
1539
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
2
Cleared 510(K)
K
19
3140
Flex Body SPEEDER
2
Cleared 510(K)
K
19
0668
Encompass 15 Channel Head Coil, 3T
2
Cleared 510(K)
K
18
2737
3T 32 Channel Head Coil
2
Cleared 510(K)
K
18
3186
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24
2
Cleared 510(K)
K
18
3111
Contour 24
2
Cleared 510(K)
K
18
2958
1.5T 16ch Breast Coil
2
Cleared 510(K)
K
18
1948
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
2
Cleared 510(K)
K
18
2590
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
2
Cleared 510(K)
K
18
2504
3.0T Air MP M, 3.0T Air MP L
2
Cleared 510(K)
K
18
1697
16ch Foot/ Ankle SPEEDER
2
Cleared 510(K)
K
18
0666
48CH Head Coil
2
Cleared 510(K)
K
16
3661
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
2
Cleared 510(K)
K
18
0123
Breast BI 7 MR Coil 1.5T Mammavention
2
Cleared 510(K)
K
17
3469
16ch T/R Hand Wrist Coil
2
Cleared 510(K)
K
17
2222
8ch Flex Suite
2
Cleared 510(K)
K
17
3377
3.0T 16ch Breast Coil
2
Cleared 510(K)
K
17
3290
DuoFLEX Coil Suite
2
Cleared 510(K)
K
17
2695
AIR Anterior Array, AIR Posterior Array
2
Cleared 510(K)
K
17
3446
Contour 24
2
Cleared 510(K)
K
17
1515
NHAC 16
2
Cleared 510(K)
K
16
2651
Breast BI 7 MR Coil Mammavention 3T
2
Cleared 510(K)
K
16
3205
48CH Head Coil
2
Cleared 510(K)
K
16
2946
8ch Knee-Foot SPEEDER
2
Cleared 510(K)
K
16
2623
16ch T/R Hand Wrist Coil
2
Cleared 510(K)
K
16
2966
TxRx Knee 15 Flare MR Coil 1.5T
2
Cleared 510(K)
K
16
3066
TxRx Knee 15 Flare MR Coil 3.0T
2
Cleared 510(K)
K
16
2863
dS Small Extremity 16CH 1.5T Coil
2
Cleared 510(K)
K
16
2029
16ch T/R Knee Coil
2
Cleared 510(K)
K
16
2079
TRILLIUM Oval Head Coil 32
2
Cleared 510(K)
K
16
2177
dS FootAnkle I6CH 1.5T Coil
2
Cleared 510(K)
K
16
2001
1.5T and 3.0T 16 CH GE Shoulder Coils
2
Cleared 510(K)
K
16
0932
8ch Foot Ankle Coil
2
Cleared 510(K)
K
16
0935
8ch Foot Ankle Coil
2
Cleared 510(K)
K
16
1193
16ch Tx/Rx Knee SPEEDER
2
Cleared 510(K)
K
15
2695
8 CH Knee SPEEDER
2
Cleared 510(K)
K
15
1753
16 ch Tx/Rx Knee SPEEDER
2
Cleared 510(K)
K
15
1653
8ch Foot Ankle Coil
2
Cleared 510(K)
K
15
1829
Atlas SPEEDER Header/Neck
2
Cleared 510(K)
K
15
0331
18ch T/R Knee Coil
2
Cleared 510(K)
K
14
3389
3.0T GEM RT Open Array
2
Cleared 510(K)
K
14
2676
Siemens 3.0T PROCURE Array Coil
2
Cleared 510(K)
K
14
2802
Atlas SPEEDER Head/Neck
2
Cleared 510(K)
K
14
2755
Siemens 3.0 Blanket Array Coil
2
Cleared 510(K)
K
14
2002
BREAST SPEEDER CX, GRID HOLDER CX
2
Cleared 510(K)
K
13
3506
NORAS OR HEAD HOLDER FLEXIBILITY
2
Cleared 510(K)
K
14
1832
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
2
Cleared 510(K)
K
14
0998
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
2
Cleared 510(K)
K
14
0606
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
2
Cleared 510(K)
K
14
0252
16 CH MULTIPURPOSE COIL VARIETY
2
Cleared 510(K)
K
14
0282
ST SENSE NV 8 ARRAY COIL
2
Cleared 510(K)
K
13
3986
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
2
Cleared 510(K)
K
13
2444
ATAMA SYSTEM
2
Cleared 510(K)
K
13
3422
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE
2
Cleared 510(K)
K
13
0706
DUOFLEX COIL SUITE (1.5T)
2
Cleared 510(K)
K
13
0457
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
2
Cleared 510(K)
K
12
3708
SPINE COIL
2
Cleared 510(K)
K
12
3272
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
2
Cleared 510(K)
K
12
3681
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
2
Cleared 510(K)
K
12
3327
1.5T GEM RT OPEN ARRAY
2
Cleared 510(K)
K
12
3091
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
2
Cleared 510(K)
K
12
2897
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
2
Cleared 510(K)
K
12
3492
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
2
Cleared 510(K)
K
12
2646
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
2
Cleared 510(K)
K
12
2694
GE 8CH FOOT ANKLE COIL
2
Cleared 510(K)
K
12
2638
TOSHIBA 3T 32CH HEAD SPEEDER COIL,
2
Cleared 510(K)
K
12
1911
OCTAVE SPEEDER SPINE
2
Cleared 510(K)
K
12
1910
OCTAVE SPEEDER HEAD
2
Cleared 510(K)
K
12
1362
1.5T 16CH FLEX SPEEDER LARGE
2
Cleared 510(K)
K
12
1249
MULTIARRAY KIT
2
Cleared 510(K)
K
12
0627
TOSHIBA 1.5T QD HEAD COIL
2
Cleared 510(K)
K
11
3365
INFANT ARRAY
2
Cleared 510(K)
K
11
3474
1.5T GEM FLEX COIL
2
Cleared 510(K)
K
12
0290
TOSHIBA 1.5T CARDIAC COIL
2
Cleared 510(K)
K
12
0122
SENSE MSK S 8CH 1.5T
2
Cleared 510(K)
K
11
1673
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
2
Cleared 510(K)
K
11
3280
CAROTID COIL GE 1.5T
2
Cleared 510(K)
K
11
2002
CAROTID COIL
2
Cleared 510(K)
K
11
2293
HTS EXTREMITY COIL, HTS SURFACE COIL
2
Cleared 510(K)
K
11
2366
4CH FLEX SPEEDER
2
Cleared 510(K)
K
11
2313
TOSHIBA 3T EXTRA LARGE KNEE COIL
2
Cleared 510(K)
K
11
1060
MRGFUS PELVIC PA COIL MODEL 1.0
2
Cleared 510(K)
K
11
1802
SV BRAIN ARRAY, SIEMENS 3T
2
Cleared 510(K)
K
11
2112
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
2
Cleared 510(K)
K
10
3274
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
2
Cleared 510(K)
K
11
1259
SV DBS VRAIN ARRAY
2
Cleared 510(K)
K
11
1251
4CH FLEX SPEEDER
2
Cleared 510(K)
K
10
2748
31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
2
Cleared 510(K)
K
11
0487
FLEXIBLE CARDIAC COIL
2
Cleared 510(K)
K
11
0411
ATAMA SYSTEM
2
Cleared 510(K)
K
11
0373
TEMPOROMANIBULAR COIL 15
2
Cleared 510(K)
K
11
0610
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
2
Cleared 510(K)
K
11
0591
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
2
Cleared 510(K)
K
10
3335
GEM OPTION FOR 1.5 MRI SYSTEMS
2
Cleared 510(K)
K
11
0120
ECHELON RAPID CARDIAC COIL
2
Cleared 510(K)
K
10
3185
TOSHIBA 1.5T EXTRA LARGE KNEE COIL
2
Cleared 510(K)
K
10
3506
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
2
Cleared 510(K)
K
10
3365
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
2
Cleared 510(K)
K
10
3275
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
2
Cleared 510(K)
K
10
3149
1.5T 16-CHANNEL HAND-WRIST COIL
2
Cleared 510(K)
K
10
3342
3.0T METAFLEXCOIL
2
Cleared 510(K)
K
10
2348
31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T
2
Cleared 510(K)
K
10
2889
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
2
Cleared 510(K)
K
09
3689
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
2
Cleared 510(K)
K
10
0141
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
2
Cleared 510(K)
K
10
1632
METAFLEXCOIL
2
Cleared 510(K)
K
09
1047
NEONATE ARRAY COILS
2
Cleared 510(K)
K
10
1949
PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
2
Cleared 510(K)
K
10
1858
PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
2
Cleared 510(K)
K
10
1492
8 CHANNEL CARDIAC PHASED ARRAY COIL
2
Cleared 510(K)
K
10
0113
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
2
Cleared 510(K)
K
10
0670
S-SCAN, MODEL 9800020010
2
Cleared 510(K)
K
09
3842
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
2
Cleared 510(K)
K
09
3284
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
2
Cleared 510(K)
K
09
3667
SHOULDER SPEEDER COIL
2
Cleared 510(K)
K
09
3693
NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
2
Cleared 510(K)
K
09
3348
3.0T 16 CHANNEL HEAD NECK SPINE COIL
2
Cleared 510(K)
K
09
2962
CAROTID COIL 5000004901
2
Cleared 510(K)
K
09
1902
1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484
2
Cleared 510(K)
K
09
1546
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
2
Cleared 510(K)
K
09
1114
TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL
2
Cleared 510(K)
K
08
3539
INFANT CARDIAC ARRAY
2
Cleared 510(K)
K
09
0267
SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
2
Cleared 510(K)
K
08
3541
NEONATE HEAD AND BODY COILS
2
Cleared 510(K)
K
08
3578
NORAS CPC MULTIFUNCTIONAL COIL
2
Cleared 510(K)
K
08
3166
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
2
Cleared 510(K)
K
08
3434
TT1 GENERAL PURPOSE COIL
2
Cleared 510(K)
K
08
3086
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
2
Cleared 510(K)
K
08
3255
16CH AI BREAST COILS 1.5 T AND 3 T
2
Cleared 510(K)
K
08
3160
1.5T ATLAS SPEEDER HEAD-NECK COIL
2
Cleared 510(K)
K
08
2987
HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
2
Cleared 510(K)
K
08
3014
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
2
Cleared 510(K)
K
08
2916
HRB-127-32 HIGH RESOLUTION BRAIN COIL
2
Cleared 510(K)
K
08
2636
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
2
Cleared 510(K)
K
08
2373
NORAS MR-BI320-PA 3T
2
Cleared 510(K)
K
08
1745
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
2
Cleared 510(K)
K
08
1340
PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
2
Cleared 510(K)
K
08
1322
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
2
Cleared 510(K)
K
08
1198
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
2
Cleared 510(K)
K
08
1118
NORAS MR-BI320-PA 1.5T
2
Cleared 510(K)
K
08
0820
TEM 3002G- HN DUAL TUNE HEAD COIL
2
Cleared 510(K)
K
08
0120
HFO SHOULDER COIL
2
Cleared 510(K)
K
08
0062
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
2
Cleared 510(K)
K
07
3310
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
2
Cleared 510(K)
K
07
3131
MICROMRI WRIST COIL
2
Cleared 510(K)
K
07
3236
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE
2
Cleared 510(K)
K
07
3181
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
2
Cleared 510(K)
K
07
2873
LBS-63-16 BREAST ARRAY COIL
2
Cleared 510(K)
K
07
2874
LBS-127-16 BREAST ARRAY COIL
2
Cleared 510(K)
K
07
2935
SPEEDER 1.5T WRIST ARRAY COIL
2
Cleared 510(K)
K
07
2909
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
2
Cleared 510(K)
K
07
2931
MC 3003G-32R HEAD COIL
2
Cleared 510(K)
K
07
1966
1.5T MRGFUS PELVIC COIL
2
Cleared 510(K)
K
07
1847
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL
2
Cleared 510(K)
K
07
1882
MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
2
Cleared 510(K)
K
07
1534
CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
2
Cleared 510(K)
K
07
1611
NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
2
Cleared 510(K)
K
07
1179
NORAS OR HEAD HOLDER
2
Cleared 510(K)
K
07
1311
NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
2
Cleared 510(K)
K
07
0778
NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL
2
Cleared 510(K)
K
07
0629
FLEX AND LOOP COIL SET 1.5 T
2
Cleared 510(K)
K
06
3513
ECHELON MR-RCC-150 CARDIAC COIL
2
Cleared 510(K)
K
06
3342
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
2
Cleared 510(K)
K
06
3373
FLEX LOOP COIL SET 3T
2
Cleared 510(K)
K
06
2767
CTL-63 AND CTL-128 SPINE ARRAY COILS
2
Cleared 510(K)
K
06
2556
ECHELON SHOULDER COIL
2
Cleared 510(K)
K
06
1950
HHF1 ECHELON MULTI-PURPOSE COIL
2
Cleared 510(K)
K
06
1952
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16
2
Cleared 510(K)
K
06
1715
MRGFUS GENERAL PURPOSE AND BREAST COIL
2
Cleared 510(K)
K
06
1281
INSIGHT HEAD COIL
2
Cleared 510(K)
K
06
1170
3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
2
Cleared 510(K)
K
06
0758
OR HEAD COIL 1.5 T
2
Cleared 510(K)
K
06
0873
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS
2
Cleared 510(K)
K
06
0689
1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL
2
Cleared 510(K)
K
06
0547
ACCESS BREAST COIL 4/SMS
2
Cleared 510(K)
K
06
0401
MEDRAD 3.0T ECOIL IMAGING SYSTEM
2
Cleared 510(K)
K
05
3042
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
2
Cleared 510(K)
K
05
3017
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
2
Cleared 510(K)
K
05
2916
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
2
Cleared 510(K)
K
05
2704
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
2
Cleared 510(K)
K
05
2827
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
2
Cleared 510(K)
K
05
2497
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
2
Cleared 510(K)
K
05
2621
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
2
Cleared 510(K)
K
05
2584
1.5T 12 CHANNEL BODY ARRAY
2
Cleared 510(K)
K
05
2585
3T HD BREAST ARRAY
2
Cleared 510(K)
K
05
2045
ACCESS BREAST COIL
2
Cleared 510(K)
K
05
2200
TEM 3000 HEAD COIL
2
Cleared 510(K)
K
05
2077
G-SCAN CERVICAL SPINE COIL
2
Cleared 510(K)
K
05
1618
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
2
Cleared 510(K)
K
05
1763
QD KNEE/FOOT COIL, MODEL MJQJ-147A
2
Cleared 510(K)
K
05
1512
CAC-127-8 CARDOAC ARRAY COIL
2
Cleared 510(K)
K
05
0728
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
2
Cleared 510(K)
K
05
1349
3.0T PROSTATE IMAGING SYSTEM
2
Cleared 510(K)
K
05
0622
HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL
2
Cleared 510(K)
K
05
0621
NVA-127-8-A NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
05
0514
MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
2
Cleared 510(K)
K
05
0476
CORDLESS COIL
2
Cleared 510(K)
K
05
0307
AIRIS ELITE RAPID BODY COIL
2
Cleared 510(K)
K
05
0299
HRK-123 KNEE ARRAY COIL
2
Cleared 510(K)
K
04
2718
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
2
Cleared 510(K)
K
04
2617
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
2
Cleared 510(K)
K
04
2844
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
2
Cleared 510(K)
K
04
2342
MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL
2
Cleared 510(K)
K
04
2207
11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
2
Cleared 510(K)
K
04
2186
3.0T 8-CHANNEL CTL SPINE ARRAY
2
Cleared 510(K)
K
04
2103
NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
04
2009
MARK III PHASED ARRAY SHOULDER COIL
2
Cleared 510(K)
K
04
1921
GE SIGNA PROFILE 6 INCH GP COIL
2
Cleared 510(K)
K
04
1481
MODEL BBC-127 BIOPSY BREAST COIL
2
Cleared 510(K)
K
04
1487
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
2
Cleared 510(K)
K
04
1185
TORSO ARRAY COIL, MODEL 558GE-64
2
Cleared 510(K)
K
04
1145
MODIFICATION TO E-SCAN XQ MRI SYSTEM
2
Cleared 510(K)
K
04
0937
TEM 3000 HEAD COIL
2
Cleared 510(K)
K
04
0122
MAYO CLINIC BC-10 3.0T
2
Cleared 510(K)
K
04
0640
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
2
Cleared 510(K)
K
04
0349
MODIFICATION TO HRW-127 WRIST ARRAY COIL
2
Cleared 510(K)
K
04
0348
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
04
0288
QSC-127-INT SHOULDER ARRAY COIL SET
2
Cleared 510(K)
K
03
3662
SYNERGY SPINE ARRAY COIL
2
Cleared 510(K)
K
03
3490
SPIRIT 5000 CARDIAC COIL
2
Cleared 510(K)
K
03
3753
PELVIC ARRAY COIL
2
Cleared 510(K)
K
03
3235
GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL
2
Cleared 510(K)
K
03
3292
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
2
Cleared 510(K)
K
03
3567
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
2
Cleared 510(K)
K
03
3353
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
2
Cleared 510(K)
K
03
2576
BIOPSY BREAST COIL, MODEL BBC
2
Cleared 510(K)
K
03
3151
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
2
Cleared 510(K)
K
03
3152
HAC-12 AND HAC-30 HEAD ARRAY COIL
2
Cleared 510(K)
K
03
2633
HRK-63-8 KNEE ARRAY COIL
2
Cleared 510(K)
K
03
2618
3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
2
Cleared 510(K)
K
03
2538
3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
2
Cleared 510(K)
K
03
2474
3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL
2
Cleared 510(K)
K
03
2415
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
2
Cleared 510(K)
K
03
2429
QSC-127 SHOULDER ARRAY COIL SET
2
Cleared 510(K)
K
03
2090
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
2
Cleared 510(K)
K
03
2045
8 CHANNEL CARDIAC PHASED ARRAY COIL
2
Cleared 510(K)
K
03
1536
BRAIN COIL, MODEL 9900GE-64
2
Cleared 510(K)
K
03
1365
PRIMA III TOTALSENSE TORSO COIL
2
Cleared 510(K)
K
03
1119
MAYO CLINIC BC-10 1.5T
2
Cleared 510(K)
K
03
1366
PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
2
Cleared 510(K)
K
03
1095
SENSE BODY COIL
2
Cleared 510(K)
K
03
1172
SPIRIT III TOTALSENSE CARDIAC COIL
2
Cleared 510(K)
K
03
1143
ALPHA 5000 WRIST COIL
2
Cleared 510(K)
K
03
1139
PREMIER III PHASED ARRAY CTL SPINE COIL
2
Cleared 510(K)
K
03
1209
GE 1.5T 8 CHANNEL TORSO COIL
2
Cleared 510(K)
K
03
1089
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
2
Cleared 510(K)
K
03
1056
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
2
Cleared 510(K)
K
03
0371
PRIMA III TOTALSENSE TORSO COIL
2
Cleared 510(K)
K
03
0540
HTS ARRAY COIL
2
Cleared 510(K)
K
03
0953
GE 3.0T GENERAL PURPOSE FLEX COIL
2
Cleared 510(K)
K
03
0317
MODEL 1300GE-64: PEDIATRIC POSITIONER
2
Cleared 510(K)
K
03
0495
3.0T TORSO PHASED ARRAY COIL
2
Cleared 510(K)
K
03
0042
PREMIER III PHASED ARRAY CTL SPINE COIL
2
Cleared 510(K)
K
02
3982
LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL
2
Cleared 510(K)
K
02
3929
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
02
3848
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
2
Cleared 510(K)
K
02
4187
SPIRIT III TOTALSENSE CARDIAC COIL
2
Cleared 510(K)
K
02
2863
HTS COIL
2
Cleared 510(K)
K
02
3650
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
2
Cleared 510(K)
K
02
4352
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
2
Cleared 510(K)
K
02
4354
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
2
Cleared 510(K)
K
02
4209
QWH-250-PAN WRIST ARRAY COIL
2
Cleared 510(K)
K
02
4208
OBC-250-PAN BREAST ARRAY COIL
2
Cleared 510(K)
K
02
3247
CHAMPION 5000 PERIPHERAL VASCULAR COIL
2
Cleared 510(K)
K
02
3084
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
2
Cleared 510(K)
K
02
3571
6 CHANNEL BODY COIL
2
Cleared 510(K)
K
02
3679
GORE 3.0T TORSO ARRAY
2
Cleared 510(K)
K
02
3596
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
2
Cleared 510(K)
K
02
3442
EXTRA LARGE BODY COIL
2
Cleared 510(K)
K
02
2007
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
2
Cleared 510(K)
K
02
2582
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
2
Cleared 510(K)
K
02
3164
BBC-63-GE BREAST ARRAY COIL
2
Cleared 510(K)
K
02
2910
QSC-63-INT SHOULDER ARRAY COIL SET
2
Cleared 510(K)
K
02
2883
HRK-63 KNEE ARRAY COIL
2
Cleared 510(K)
K
02
2720
CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL
2
Cleared 510(K)
K
02
2669
8 CHANNEL CARDIAC PHASED ARRAY COIL
2
Cleared 510(K)
K
02
2588
HRW-63-INT WRIST ARRAY COIL
2
Cleared 510(K)
K
02
2488
MODEL OBC-63 BREAST ARRAY COIL
2
Cleared 510(K)
K
02
2487
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
2
Cleared 510(K)
K
02
1751
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
2
Cleared 510(K)
K
02
2395
1.5T SCANMED PV ARRAY
2
Cleared 510(K)
K
02
2372
HRH-127-8 HEAD ARRAY COIL
2
Cleared 510(K)
K
02
1631
ISA-21 INTERVENTIONAL SPINE ARRAY COIL
2
Cleared 510(K)
K
02
1330
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
2
Cleared 510(K)
K
02
1141
MILLENNIUM 5000 MEUROVASCULAR COIL
2
Cleared 510(K)
K
02
1433
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
2
Cleared 510(K)
K
02
1575
OBC-127 BREAST ARRAY COIL
2
Cleared 510(K)
K
02
1570
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
02
0850
GPF-29 GENERAL PURPOSE COIL SET
2
Cleared 510(K)
K
02
1262
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
2
Cleared 510(K)
K
02
0993
ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)
2
Cleared 510(K)
K
02
0790
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
2
Cleared 510(K)
K
02
0601
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
2
Cleared 510(K)
K
02
0495
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
2
Cleared 510(K)
K
02
0606
NVA-63-8 NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
01
3854
MARK 5000 QUADRATURE SHOULDER COIL
2
Cleared 510(K)
K
01
4086
CTL BODY / SPINE ARRAY COIL
2
Cleared 510(K)
K
02
0036
EXS-63 SMALL EXTREMITY ARRAY COIL
2
Cleared 510(K)
K
01
3985
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
2
Cleared 510(K)
K
01
3594
BODY ARRAY COIL
2
Cleared 510(K)
K
01
3595
PREMIER III PHASED ARRAY CTL SPINE COIL
2
Cleared 510(K)
K
01
3894
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
2
Cleared 510(K)
K
01
3592
EXTREMITY COIL
2
Cleared 510(K)
K
01
3514
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
2
Cleared 510(K)
K
01
3541
SHOULDER COIL
2
Cleared 510(K)
K
01
3528
CRYSTAL 5000 PHASES ARRAY TMJ COIL
2
Cleared 510(K)
K
01
1683
NURVO 9000 ENDOCAVITARY COILS
2
Cleared 510(K)
K
01
3810
CARDIOVASCULAR ARRAY
2
Cleared 510(K)
K
01
3602
HNC-63-INT NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
01
3508
HRH-127-ALLEGRA HEAD ARRAY COIL
2
Cleared 510(K)
K
01
2491
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
2
Cleared 510(K)
K
01
3322
HAC-420 HEAD ARRAY COIL
2
Cleared 510(K)
K
01
3159
HRH-63-8 HEAD ARRAY COIL
2
Cleared 510(K)
K
01
3099
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
2
Cleared 510(K)
K
01
1781
INTERCEPT-URETHRAL MICROCOIL
2
Cleared 510(K)
K
01
2728
E-SCAN MRI SYSTEM
2
Cleared 510(K)
K
01
2353
HNC-127 NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
01
1608
MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
2
Cleared 510(K)
K
01
0802
CARDIAC VIEW, MODEL 2001
2
Cleared 510(K)
K
01
0946
MARK 9000 PHASED ARRAY SHOULDER COIL
2
Cleared 510(K)
K
00
3505
KFA-127 KNEE, FOOT AND ANKLE ARRAY
2
Cleared 510(K)
K
01
0513
CARDIAC VIEW, MODEL 2001
2
Cleared 510(K)
K
01
0730
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
2
Cleared 510(K)
K
01
0074
MODEL 455GE PHASED ARRAY WRIST COIL
2
Cleared 510(K)
K
00
3613
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
2
Cleared 510(K)
K
00
3946
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
2
Cleared 510(K)
K
01
0140
HRH-127 HEAD ARRAY COIL
2
Cleared 510(K)
K
00
3655
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
2
Cleared 510(K)
K
00
3436
SURGI-VISION GUIDEWIRE COIL
2
Cleared 510(K)
K
00
1097
ACTIVE ARRAY CATHETER, MODEL CS-2000
2
Cleared 510(K)
K
00
3386
SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64
2
Cleared 510(K)
K
00
3097
BRAIN COIL, MODEL 9800GE-64
2
Cleared 510(K)
K
00
3685
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
2
Cleared 510(K)
K
00
3366
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
2
Cleared 510(K)
K
00
3144
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
2
Cleared 510(K)
K
00
2916
SURGI-VISION PROSTATE COIL
2
Cleared 510(K)
K
00
2860
MODEL 6900GE-64: C-SPINE ARRAY
2
Cleared 510(K)
K
00
2864
MODEL 6600GE-64: TRAMA NECK ARRAY
2
Cleared 510(K)
K
00
2774
HRH-63 HEAD ARRAY COIL
2
Cleared 510(K)
K
00
3340
OBC-149 BREAST ARRAY COIL
2
Cleared 510(K)
K
00
3331
QWH-149 WRIST ARRAY COIL
2
Cleared 510(K)
K
00
2522
OPART, MODEL MRT-600
2
Cleared 510(K)
K
00
2483
POWER 5000 GENERAL PURPOSE COIL
2
Cleared 510(K)
K
00
2482
VISION 9000 PHASED ARRAY TORSO COIL
2
Cleared 510(K)
K
00
2345
SURGI-VISION URETHRAL COIL
2
Cleared 510(K)
K
00
2602
OBC-63 MEBREAST ARRAY COIL
2
Cleared 510(K)
K
00
2539
OBC-096 BREAST ARRAY COIL
2
Cleared 510(K)
K
00
1946
NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
00
1944
HAC-300 HEAD ARRAY COIL
2
Cleared 510(K)
K
00
1870
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
2
Cleared 510(K)
K
00
1582
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
2
Cleared 510(K)
K
00
1312
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
2
Cleared 510(K)
K
00
1303
BREAST IMMOBILIZATION DEVICE MR-BY 160
2
Cleared 510(K)
K
00
1713
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
2
Cleared 510(K)
K
00
1331
SYNERGY HEAD/NECK COIL
2
Cleared 510(K)
K
00
1210
HI-RES 9000 PHASED ARRAY CAROTID COIL
2
Cleared 510(K)
K
00
1209
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
2
Cleared 510(K)
K
00
0993
LIBERTY 9000 BREAST COIL
2
Cleared 510(K)
K
00
0549
OPART, MODEL MRT-600
2
Cleared 510(K)
K
00
0437
INTERVENTIONAL BODY COIL
2
Cleared 510(K)
K
00
0345
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
2
Cleared 510(K)
K
00
0935
KFA-63 KNEE AND FOOT ARRAY
2
Cleared 510(K)
K
00
0589
MODEL 445SI-64E QUADRATURE WRIST COIL
2
Cleared 510(K)
K
99
4436
SURGI-VISION ESOPHAGEAL STYLET COIL
2
Cleared 510(K)
K
99
4378
AIRIS II
2
Cleared 510(K)
K
00
0002
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
2
Cleared 510(K)
K
99
4345
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
2
Cleared 510(K)
K
99
4315
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
2
Cleared 510(K)
K
99
3898
KAC-63 KNEE ARRAY COIL
2
Cleared 510(K)
K
99
4042
SHARP 9000 PHASED ARRAY BRAIN COIL
2
Cleared 510(K)
K
99
4040
PHASED ARRAY KNEE AND FOOT COIL
2
Cleared 510(K)
K
99
3819
QWH-300 WRIST ARRAY COIL
2
Cleared 510(K)
K
99
3776
OBC-300 BREAST ARRAY COIL
2
Cleared 510(K)
K
99
3780
QSC-300 SHOULDER ARRAY COILS
2
Cleared 510(K)
K
99
3719
KAC-300 KNEE ARRAY COIL
2
Cleared 510(K)
K
99
3477
HRW WRIST ARRAY COIL
2
Cleared 510(K)
K
99
3279
QSC-085 SHOULDER ARRAY COIL
2
Cleared 510(K)
K
99
3233
OBC-085 BREAST ARRAY COIL
2
Cleared 510(K)
K
99
3235
QWH-085 WRIST ARRAY COIL
2
Cleared 510(K)
K
99
2650
AIRIS, AIRIS II
2
Cleared 510(K)
K
99
2193
ENDO-ESOPHAGEAL MR COIL
2
Cleared 510(K)
K
99
1765
SYNERGY SHOULDER COIL
2
Cleared 510(K)
K
99
1740
OPART, MODEL MRT-600
2
Cleared 510(K)
K
99
1724
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
2
Cleared 510(K)
K
99
1434
QUADRATURE WRIST COIL, MODEL 445PH-64
2
Cleared 510(K)
K
99
1113
`INEAR WRIST COIL, MODEL 440GE-09
2
Cleared 510(K)
K
99
1115
LINEAR SHOULDER COIL, MODEL 414GE-09
2
Cleared 510(K)
K
99
1057
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
2
Cleared 510(K)
K
99
0007
OPART, MODEL MRT-600
2
Cleared 510(K)
K
98
3139
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL
2
Cleared 510(K)
K
98
4588
PHASED ARRAY FLEXIBLE CARDIAC COIL
2
Cleared 510(K)
K
98
4257
MEDRAD PHASED ARRAY NEUROVASCULAR COIL
2
Cleared 510(K)
K
98
4159
MEDRAD QUADRATURE CTL ARRAY COIL
2
Cleared 510(K)
K
98
4278
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
2
Cleared 510(K)
K
98
4272
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
2
Cleared 510(K)
K
98
2978
MODEL 340GE-21C QUADRATURE BRAIN COIL
2
Cleared 510(K)
K
98
3143
MARK 5000 PHASED ARRAY SHOULDER COIL
2
Cleared 510(K)
K
98
2972
SIGNA PROFILE SMALL HEAD COIL
2
Cleared 510(K)
K
98
2921
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
2
Cleared 510(K)
K
98
2919
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
2
Cleared 510(K)
K
98
2916
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
2
Cleared 510(K)
K
98
2772
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL
2
Cleared 510(K)
K
98
3222
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
2
Cleared 510(K)
K
98
3109
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY
2
Cleared 510(K)
K
98
2496
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
2
Cleared 510(K)
K
98
2339
FLOW 7000 PERIPHERAL VASCULAR COIL
2
Cleared 510(K)
K
98
1959
OUTLOOK LARGE PHASED ARRAY NECK COIL
2
Cleared 510(K)
K
98
1406
CERVIX COIL LATEX SHEATH
2
Cleared 510(K)
K
98
1094
MEDRAD NEUROVASCULAR COIL
2
Cleared 510(K)
K
98
0691
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
2
Cleared 510(K)
K
97
4438
MEDRAD ATD-T INTERFACE DEVICE
2
Cleared 510(K)
K
98
0157
PREMIER 7000 CTL SPINE COIL
2
Cleared 510(K)
K
97
4308
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
2
Cleared 510(K)
K
97
3787
MEDRAD 1.5T EXTREMITY ARRAY
2
Cleared 510(K)
K
97
3630
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
2
Cleared 510(K)
K
97
2592
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
2
Cleared 510(K)
K
97
2296
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
97
2205
ALPHA 7000 QUADRATURE WRIST COIL
2
Cleared 510(K)
K
97
2340
INSIGHT 7000 PHASED ARRAY TORSO COIL
2
Cleared 510(K)
K
97
1667
CARDIAC PHASED ARRAY COIL
2
Cleared 510(K)
K
96
4969
SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
2
Cleared 510(K)
K
97
1246
LEO 7000 QUADRATURE KNEE COIL
2
Cleared 510(K)
K
97
1016
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
2
Cleared 510(K)
K
97
0868
MODEL HNC NEUROVASCULAR ARRAY COIL
2
Cleared 510(K)
K
96
4820
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
2
Cleared 510(K)
K
96
4813
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
2
Cleared 510(K)
K
96
4668
MODELS EXL AND EXS EXTREMITY COIL SET
2
Cleared 510(K)
K
96
4854
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
2
Cleared 510(K)
K
96
4678
PHASED ARRAY NECK COIL
2
Cleared 510(K)
K
96
4141
GE STERILE DISPOSABLE EQUIPMENT COIL COVER
2
Cleared 510(K)
K
96
3356
PHASED ARRAY SHOULDER COIL
2
Cleared 510(K)
K
96
1628
MINI FLEX COIL
2
Cleared 510(K)
K
96
1525
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
2
Cleared 510(K)
K
96
1391
FLEXART QD HEAD/NECK COIL
2
Cleared 510(K)
K
95
4952
MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL
2
Cleared 510(K)
K
95
5626
MEDRAD/HITACHI BREAST IMAGING SURFACE COIL
2
Cleared 510(K)
K
95
4190
MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
2
Cleared 510(K)
K
95
3595
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
2
Cleared 510(K)
K
95
2944
MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL
2
Cleared 510(K)
K
95
0966
MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE
2
Cleared 510(K)
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 30 November 2024 at 11:09 am
RA
/
subpart-b—diagnostic-devices
/
MOS
/
K031056
View Source
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K031056
510(k) Type
Special
Applicant
USA INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2003
Days to Decision
35 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
LNI
System, Nuclear Magnetic Resonance Spectroscopic
LQA
Media, Reusable Image
MOS
Coil, Magnetic Resonance, Specialty
K
24
3316
XENOVIEW 3.0T Chest Coil
K
24
3033
dS Wrist coil 8ch 1.5T
K
24
2879
dS Knee Coil 8ch 1.5T
K
24
2096
dS FootAnkle Coil 8ch 1.5T
K
24
1069
iLoop Interventional Coil 0.55T
K
23
3652
Contour Hand/Wrist (Q7000232)
K
23
3656
Contour Shoulder
K
23
3600
Smart Fit Knee 3.0T
K
23
3444
InkSpace Imaging Small Body Array
K
23
3348
16 Breast Coil
K
23
2762
dS Breast Coil 7ch 1.5T
K
23
2021
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
K
23
1085
1.5T HD T/R Knee Array (10-F34127)
K
22
3484
IGAR System (1001.A)
K
23
1647
XENOVIEW 3.0T Chest Coil
K
22
3225
8ch T/R Knee Coil
K
21
3480
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
K
22
3429
Contour Knee
K
22
3378
3.0T 16ch AIR AA
K
21
2239
XENOVIEW 3.0T Chest Coil
K
22
3487
InkSpace Imaging Body Array
K
22
3239
8ch Wrist Coil
K
22
2407
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
K
22
2325
8ch Wrist Coil
K
22
2257
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
K
21
3735
dS Sentinelle Breast 16ch 1.5T Coil
K
21
3727
dS Sentinelle Breast 16ch 3.0T Coil
K
22
0144
Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
K
21
3687
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
K
21
1658
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
K
21
3766
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
K
21
3397
InkSpace Imaging Pediatric Body Array
K
21
2864
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
K
21
3351
ds Head 32ch 3.0T
K
20
0836
8ch Flex Suite
K
20
1101
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
K
20
0477
Flex Body Speeder
K
19
1539
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
K
19
3140
Flex Body SPEEDER
K
19
0668
Encompass 15 Channel Head Coil, 3T
K
18
2737
3T 32 Channel Head Coil
K
18
3186
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24
K
18
3111
Contour 24
K
18
2958
1.5T 16ch Breast Coil
K
18
1948
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
K
18
2590
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
K
18
2504
3.0T Air MP M, 3.0T Air MP L
K
18
1697
16ch Foot/ Ankle SPEEDER
K
18
0666
48CH Head Coil
K
16
3661
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
K
18
0123
Breast BI 7 MR Coil 1.5T Mammavention
K
17
3469
16ch T/R Hand Wrist Coil
K
17
2222
8ch Flex Suite
K
17
3377
3.0T 16ch Breast Coil
K
17
3290
DuoFLEX Coil Suite
K
17
2695
AIR Anterior Array, AIR Posterior Array
K
17
3446
Contour 24
K
17
1515
NHAC 16
K
16
2651
Breast BI 7 MR Coil Mammavention 3T
K
16
3205
48CH Head Coil
K
16
2946
8ch Knee-Foot SPEEDER
K
16
2623
16ch T/R Hand Wrist Coil
K
16
2966
TxRx Knee 15 Flare MR Coil 1.5T
K
16
3066
TxRx Knee 15 Flare MR Coil 3.0T
K
16
2863
dS Small Extremity 16CH 1.5T Coil
K
16
2029
16ch T/R Knee Coil
K
16
2079
TRILLIUM Oval Head Coil 32
K
16
2177
dS FootAnkle I6CH 1.5T Coil
K
16
2001
1.5T and 3.0T 16 CH GE Shoulder Coils
K
16
0932
8ch Foot Ankle Coil
K
16
0935
8ch Foot Ankle Coil
K
16
1193
16ch Tx/Rx Knee SPEEDER
K
15
2695
8 CH Knee SPEEDER
K
15
1753
16 ch Tx/Rx Knee SPEEDER
K
15
1653
8ch Foot Ankle Coil
K
15
1829
Atlas SPEEDER Header/Neck
K
15
0331
18ch T/R Knee Coil
K
14
3389
3.0T GEM RT Open Array
K
14
2676
Siemens 3.0T PROCURE Array Coil
K
14
2802
Atlas SPEEDER Head/Neck
K
14
2755
Siemens 3.0 Blanket Array Coil
K
14
2002
BREAST SPEEDER CX, GRID HOLDER CX
K
13
3506
NORAS OR HEAD HOLDER FLEXIBILITY
K
14
1832
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
K
14
0998
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
K
14
0606
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
K
14
0252
16 CH MULTIPURPOSE COIL VARIETY
K
14
0282
ST SENSE NV 8 ARRAY COIL
K
13
3986
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
K
13
2444
ATAMA SYSTEM
K
13
3422
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE
K
13
0706
DUOFLEX COIL SUITE (1.5T)
K
13
0457
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
K
12
3708
SPINE COIL
K
12
3272
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
K
12
3681
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
K
12
3327
1.5T GEM RT OPEN ARRAY
K
12
3091
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
K
12
2897
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
K
12
3492
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
K
12
2646
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
K
12
2694
GE 8CH FOOT ANKLE COIL
K
12
2638
TOSHIBA 3T 32CH HEAD SPEEDER COIL,
K
12
1911
OCTAVE SPEEDER SPINE
K
12
1910
OCTAVE SPEEDER HEAD
K
12
1362
1.5T 16CH FLEX SPEEDER LARGE
K
12
1249
MULTIARRAY KIT
K
12
0627
TOSHIBA 1.5T QD HEAD COIL
K
11
3365
INFANT ARRAY
K
11
3474
1.5T GEM FLEX COIL
K
12
0290
TOSHIBA 1.5T CARDIAC COIL
K
12
0122
SENSE MSK S 8CH 1.5T
K
11
1673
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
K
11
3280
CAROTID COIL GE 1.5T
K
11
2002
CAROTID COIL
K
11
2293
HTS EXTREMITY COIL, HTS SURFACE COIL
K
11
2366
4CH FLEX SPEEDER
K
11
2313
TOSHIBA 3T EXTRA LARGE KNEE COIL
K
11
1060
MRGFUS PELVIC PA COIL MODEL 1.0
K
11
1802
SV BRAIN ARRAY, SIEMENS 3T
K
11
2112
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
K
10
3274
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
K
11
1259
SV DBS VRAIN ARRAY
K
11
1251
4CH FLEX SPEEDER
K
10
2748
31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
K
11
0487
FLEXIBLE CARDIAC COIL
K
11
0411
ATAMA SYSTEM
K
11
0373
TEMPOROMANIBULAR COIL 15
K
11
0610
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
K
11
0591
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
K
10
3335
GEM OPTION FOR 1.5 MRI SYSTEMS
K
11
0120
ECHELON RAPID CARDIAC COIL
K
10
3185
TOSHIBA 1.5T EXTRA LARGE KNEE COIL
K
10
3506
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
K
10
3365
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
K
10
3275
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K
10
3149
1.5T 16-CHANNEL HAND-WRIST COIL
K
10
3342
3.0T METAFLEXCOIL
K
10
2348
31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T
K
10
2889
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
K
09
3689
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
K
10
0141
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
K
10
1632
METAFLEXCOIL
K
09
1047
NEONATE ARRAY COILS
K
10
1949
PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
K
10
1858
PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
K
10
1492
8 CHANNEL CARDIAC PHASED ARRAY COIL
K
10
0113
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
K
10
0670
S-SCAN, MODEL 9800020010
K
09
3842
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
K
09
3284
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
K
09
3667
SHOULDER SPEEDER COIL
K
09
3693
NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
K
09
3348
3.0T 16 CHANNEL HEAD NECK SPINE COIL
K
09
2962
CAROTID COIL 5000004901
K
09
1902
1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484
K
09
1546
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
K
09
1114
TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL
K
08
3539
INFANT CARDIAC ARRAY
K
09
0267
SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
K
08
3541
NEONATE HEAD AND BODY COILS
K
08
3578
NORAS CPC MULTIFUNCTIONAL COIL
K
08
3166
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K
08
3434
TT1 GENERAL PURPOSE COIL
K
08
3086
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
K
08
3255
16CH AI BREAST COILS 1.5 T AND 3 T
K
08
3160
1.5T ATLAS SPEEDER HEAD-NECK COIL
K
08
2987
HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
K
08
3014
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K
08
2916
HRB-127-32 HIGH RESOLUTION BRAIN COIL
K
08
2636
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
K
08
2373
NORAS MR-BI320-PA 3T
K
08
1745
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
K
08
1340
PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
K
08
1322
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
K
08
1198
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
K
08
1118
NORAS MR-BI320-PA 1.5T
K
08
0820
TEM 3002G- HN DUAL TUNE HEAD COIL
K
08
0120
HFO SHOULDER COIL
K
08
0062
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
K
07
3310
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
K
07
3131
MICROMRI WRIST COIL
K
07
3236
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE
K
07
3181
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
K
07
2873
LBS-63-16 BREAST ARRAY COIL
K
07
2874
LBS-127-16 BREAST ARRAY COIL
K
07
2935
SPEEDER 1.5T WRIST ARRAY COIL
K
07
2909
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
K
07
2931
MC 3003G-32R HEAD COIL
K
07
1966
1.5T MRGFUS PELVIC COIL
K
07
1847
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL
K
07
1882
MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
K
07
1534
CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
K
07
1611
NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
K
07
1179
NORAS OR HEAD HOLDER
K
07
1311
NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
K
07
0778
NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL
K
07
0629
FLEX AND LOOP COIL SET 1.5 T
K
06
3513
ECHELON MR-RCC-150 CARDIAC COIL
K
06
3342
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
K
06
3373
FLEX LOOP COIL SET 3T
K
06
2767
CTL-63 AND CTL-128 SPINE ARRAY COILS
K
06
2556
ECHELON SHOULDER COIL
K
06
1950
HHF1 ECHELON MULTI-PURPOSE COIL
K
06
1952
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16
K
06
1715
MRGFUS GENERAL PURPOSE AND BREAST COIL
K
06
1281
INSIGHT HEAD COIL
K
06
1170
3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
K
06
0758
OR HEAD COIL 1.5 T
K
06
0873
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS
K
06
0689
1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL
K
06
0547
ACCESS BREAST COIL 4/SMS
K
06
0401
MEDRAD 3.0T ECOIL IMAGING SYSTEM
K
05
3042
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
K
05
3017
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
K
05
2916
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
K
05
2704
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
K
05
2827
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
K
05
2497
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
K
05
2621
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K
05
2584
1.5T 12 CHANNEL BODY ARRAY
K
05
2585
3T HD BREAST ARRAY
K
05
2045
ACCESS BREAST COIL
K
05
2200
TEM 3000 HEAD COIL
K
05
2077
G-SCAN CERVICAL SPINE COIL
K
05
1618
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
K
05
1763
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K
05
1512
CAC-127-8 CARDOAC ARRAY COIL
K
05
0728
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K
05
1349
3.0T PROSTATE IMAGING SYSTEM
K
05
0622
HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL
K
05
0621
NVA-127-8-A NEUROVASCULAR ARRAY COIL
K
05
0514
MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
K
05
0476
CORDLESS COIL
K
05
0307
AIRIS ELITE RAPID BODY COIL
K
05
0299
HRK-123 KNEE ARRAY COIL
K
04
2718
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
K
04
2617
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K
04
2844
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
K
04
2342
MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL
K
04
2207
11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
K
04
2186
3.0T 8-CHANNEL CTL SPINE ARRAY
K
04
2103
NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
K
04
2009
MARK III PHASED ARRAY SHOULDER COIL
K
04
1921
GE SIGNA PROFILE 6 INCH GP COIL
K
04
1481
MODEL BBC-127 BIOPSY BREAST COIL
K
04
1487
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
K
04
1185
TORSO ARRAY COIL, MODEL 558GE-64
K
04
1145
MODIFICATION TO E-SCAN XQ MRI SYSTEM
K
04
0937
TEM 3000 HEAD COIL
K
04
0122
MAYO CLINIC BC-10 3.0T
K
04
0640
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
K
04
0349
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K
04
0348
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K
04
0288
QSC-127-INT SHOULDER ARRAY COIL SET
K
03
3662
SYNERGY SPINE ARRAY COIL
K
03
3490
SPIRIT 5000 CARDIAC COIL
K
03
3753
PELVIC ARRAY COIL
K
03
3235
GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL
K
03
3292
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
K
03
3567
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
K
03
3353
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K
03
2576
BIOPSY BREAST COIL, MODEL BBC
K
03
3151
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
K
03
3152
HAC-12 AND HAC-30 HEAD ARRAY COIL
K
03
2633
HRK-63-8 KNEE ARRAY COIL
K
03
2618
3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
K
03
2538
3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
K
03
2474
3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL
K
03
2415
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
K
03
2429
QSC-127 SHOULDER ARRAY COIL SET
K
03
2090
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
K
03
2045
8 CHANNEL CARDIAC PHASED ARRAY COIL
K
03
1536
BRAIN COIL, MODEL 9900GE-64
K
03
1365
PRIMA III TOTALSENSE TORSO COIL
K
03
1119
MAYO CLINIC BC-10 1.5T
K
03
1366
PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
K
03
1095
SENSE BODY COIL
K
03
1172
SPIRIT III TOTALSENSE CARDIAC COIL
K
03
1143
ALPHA 5000 WRIST COIL
K
03
1139
PREMIER III PHASED ARRAY CTL SPINE COIL
K
03
1209
GE 1.5T 8 CHANNEL TORSO COIL
K
03
1089
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K
03
1056
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
K
03
0371
PRIMA III TOTALSENSE TORSO COIL
K
03
0540
HTS ARRAY COIL
K
03
0953
GE 3.0T GENERAL PURPOSE FLEX COIL
K
03
0317
MODEL 1300GE-64: PEDIATRIC POSITIONER
K
03
0495
3.0T TORSO PHASED ARRAY COIL
K
03
0042
PREMIER III PHASED ARRAY CTL SPINE COIL
K
02
3982
LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL
K
02
3929
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K
02
3848
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
K
02
4187
SPIRIT III TOTALSENSE CARDIAC COIL
K
02
2863
HTS COIL
K
02
3650
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
K
02
4352
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
K
02
4354
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
K
02
4209
QWH-250-PAN WRIST ARRAY COIL
K
02
4208
OBC-250-PAN BREAST ARRAY COIL
K
02
3247
CHAMPION 5000 PERIPHERAL VASCULAR COIL
K
02
3084
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
K
02
3571
6 CHANNEL BODY COIL
K
02
3679
GORE 3.0T TORSO ARRAY
K
02
3596
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
K
02
3442
EXTRA LARGE BODY COIL
K
02
2007
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K
02
2582
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
K
02
3164
BBC-63-GE BREAST ARRAY COIL
K
02
2910
QSC-63-INT SHOULDER ARRAY COIL SET
K
02
2883
HRK-63 KNEE ARRAY COIL
K
02
2720
CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL
K
02
2669
8 CHANNEL CARDIAC PHASED ARRAY COIL
K
02
2588
HRW-63-INT WRIST ARRAY COIL
K
02
2488
MODEL OBC-63 BREAST ARRAY COIL
K
02
2487
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
K
02
1751
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K
02
2395
1.5T SCANMED PV ARRAY
K
02
2372
HRH-127-8 HEAD ARRAY COIL
K
02
1631
ISA-21 INTERVENTIONAL SPINE ARRAY COIL
K
02
1330
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K
02
1141
MILLENNIUM 5000 MEUROVASCULAR COIL
K
02
1433
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
K
02
1575
OBC-127 BREAST ARRAY COIL
K
02
1570
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
K
02
0850
GPF-29 GENERAL PURPOSE COIL SET
K
02
1262
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
K
02
0993
ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)
K
02
0790
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
K
02
0601
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
K
02
0495
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
K
02
0606
NVA-63-8 NEUROVASCULAR ARRAY COIL
K
01
3854
MARK 5000 QUADRATURE SHOULDER COIL
K
01
4086
CTL BODY / SPINE ARRAY COIL
K
02
0036
EXS-63 SMALL EXTREMITY ARRAY COIL
K
01
3985
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
K
01
3594
BODY ARRAY COIL
K
01
3595
PREMIER III PHASED ARRAY CTL SPINE COIL
K
01
3894
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K
01
3592
EXTREMITY COIL
K
01
3514
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K
01
3541
SHOULDER COIL
K
01
3528
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K
01
1683
NURVO 9000 ENDOCAVITARY COILS
K
01
3810
CARDIOVASCULAR ARRAY
K
01
3602
HNC-63-INT NEUROVASCULAR ARRAY COIL
K
01
3508
HRH-127-ALLEGRA HEAD ARRAY COIL
K
01
2491
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
K
01
3322
HAC-420 HEAD ARRAY COIL
K
01
3159
HRH-63-8 HEAD ARRAY COIL
K
01
3099
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
K
01
1781
INTERCEPT-URETHRAL MICROCOIL
K
01
2728
E-SCAN MRI SYSTEM
K
01
2353
HNC-127 NEUROVASCULAR ARRAY COIL
K
01
1608
MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
K
01
0802
CARDIAC VIEW, MODEL 2001
K
01
0946
MARK 9000 PHASED ARRAY SHOULDER COIL
K
00
3505
KFA-127 KNEE, FOOT AND ANKLE ARRAY
K
01
0513
CARDIAC VIEW, MODEL 2001
K
01
0730
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K
01
0074
MODEL 455GE PHASED ARRAY WRIST COIL
K
00
3613
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K
00
3946
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K
01
0140
HRH-127 HEAD ARRAY COIL
K
00
3655
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K
00
3436
SURGI-VISION GUIDEWIRE COIL
K
00
1097
ACTIVE ARRAY CATHETER, MODEL CS-2000
K
00
3386
SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64
K
00
3097
BRAIN COIL, MODEL 9800GE-64
K
00
3685
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K
00
3366
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
K
00
3144
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
K
00
2916
SURGI-VISION PROSTATE COIL
K
00
2860
MODEL 6900GE-64: C-SPINE ARRAY
K
00
2864
MODEL 6600GE-64: TRAMA NECK ARRAY
K
00
2774
HRH-63 HEAD ARRAY COIL
K
00
3340
OBC-149 BREAST ARRAY COIL
K
00
3331
QWH-149 WRIST ARRAY COIL
K
00
2522
OPART, MODEL MRT-600
K
00
2483
POWER 5000 GENERAL PURPOSE COIL
K
00
2482
VISION 9000 PHASED ARRAY TORSO COIL
K
00
2345
SURGI-VISION URETHRAL COIL
K
00
2602
OBC-63 MEBREAST ARRAY COIL
K
00
2539
OBC-096 BREAST ARRAY COIL
K
00
1946
NEUROVASCULAR ARRAY COIL
K
00
1944
HAC-300 HEAD ARRAY COIL
K
00
1870
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
K
00
1582
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K
00
1312
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
K
00
1303
BREAST IMMOBILIZATION DEVICE MR-BY 160
K
00
1713
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
K
00
1331
SYNERGY HEAD/NECK COIL
K
00
1210
HI-RES 9000 PHASED ARRAY CAROTID COIL
K
00
1209
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
K
00
0993
LIBERTY 9000 BREAST COIL
K
00
0549
OPART, MODEL MRT-600
K
00
0437
INTERVENTIONAL BODY COIL
K
00
0345
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
K
00
0935
KFA-63 KNEE AND FOOT ARRAY
K
00
0589
MODEL 445SI-64E QUADRATURE WRIST COIL
K
99
4436
SURGI-VISION ESOPHAGEAL STYLET COIL
K
99
4378
AIRIS II
K
00
0002
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K
99
4345
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K
99
4315
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K
99
3898
KAC-63 KNEE ARRAY COIL
K
99
4042
SHARP 9000 PHASED ARRAY BRAIN COIL
K
99
4040
PHASED ARRAY KNEE AND FOOT COIL
K
99
3819
QWH-300 WRIST ARRAY COIL
K
99
3776
OBC-300 BREAST ARRAY COIL
K
99
3780
QSC-300 SHOULDER ARRAY COILS
K
99
3719
KAC-300 KNEE ARRAY COIL
K
99
3477
HRW WRIST ARRAY COIL
K
99
3279
QSC-085 SHOULDER ARRAY COIL
K
99
3233
OBC-085 BREAST ARRAY COIL
K
99
3235
QWH-085 WRIST ARRAY COIL
K
99
2650
AIRIS, AIRIS II
K
99
2193
ENDO-ESOPHAGEAL MR COIL
K
99
1765
SYNERGY SHOULDER COIL
K
99
1740
OPART, MODEL MRT-600
K
99
1724
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
K
99
1434
QUADRATURE WRIST COIL, MODEL 445PH-64
K
99
1113
`INEAR WRIST COIL, MODEL 440GE-09
K
99
1115
LINEAR SHOULDER COIL, MODEL 414GE-09
K
99
1057
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
K
99
0007
OPART, MODEL MRT-600
K
98
3139
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL
K
98
4588
PHASED ARRAY FLEXIBLE CARDIAC COIL
K
98
4257
MEDRAD PHASED ARRAY NEUROVASCULAR COIL
K
98
4159
MEDRAD QUADRATURE CTL ARRAY COIL
K
98
4278
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
K
98
4272
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
K
98
2978
MODEL 340GE-21C QUADRATURE BRAIN COIL
K
98
3143
MARK 5000 PHASED ARRAY SHOULDER COIL
K
98
2972
SIGNA PROFILE SMALL HEAD COIL
K
98
2921
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
K
98
2919
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
K
98
2916
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
K
98
2772
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL
K
98
3222
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
K
98
3109
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY
K
98
2496
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
K
98
2339
FLOW 7000 PERIPHERAL VASCULAR COIL
K
98
1959
OUTLOOK LARGE PHASED ARRAY NECK COIL
K
98
1406
CERVIX COIL LATEX SHEATH
K
98
1094
MEDRAD NEUROVASCULAR COIL
K
98
0691
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K
97
4438
MEDRAD ATD-T INTERFACE DEVICE
K
98
0157
PREMIER 7000 CTL SPINE COIL
K
97
4308
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
K
97
3787
MEDRAD 1.5T EXTREMITY ARRAY
K
97
3630
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
K
97
2592
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K
97
2296
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K
97
2205
ALPHA 7000 QUADRATURE WRIST COIL
K
97
2340
INSIGHT 7000 PHASED ARRAY TORSO COIL
K
97
1667
CARDIAC PHASED ARRAY COIL
K
96
4969
SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
K
97
1246
LEO 7000 QUADRATURE KNEE COIL
K
97
1016
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
K
97
0868
MODEL HNC NEUROVASCULAR ARRAY COIL
K
96
4820
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
K
96
4813
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
K
96
4668
MODELS EXL AND EXS EXTREMITY COIL SET
K
96
4854
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
K
96
4678
PHASED ARRAY NECK COIL
K
96
4141
GE STERILE DISPOSABLE EQUIPMENT COIL COVER
K
96
3356
PHASED ARRAY SHOULDER COIL
K
96
1628
MINI FLEX COIL
K
96
1525
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
K
96
1391
FLEXART QD HEAD/NECK COIL
K
95
4952
MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL
K
95
5626
MEDRAD/HITACHI BREAST IMAGING SURFACE COIL
K
95
4190
MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
K
95
3595
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K
95
2944
MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL
K
95
0966
MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE
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
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
/
MOS
/
K031056
View Source
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K031056
510(k) Type
Special
Applicant
USA INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2003
Days to Decision
35 days
Submission Type
Summary