Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EAGCephalometer2Product Code
- EAHCone, Radiographic, Lead-Lined1Product Code
- EAPUnit, X-Ray, Intraoral2Product Code
- EHBCollimator, X-Ray1Product Code
- EHDUnit, X-Ray, Extraoral With Timer2Product Code
- MUHSystem, X-Ray, Extraoral Source, Digital2Product Code
- EAMScreen, Intensifying, Radiographic1Product Code
- EGTController, Temperature, Radiographic2Product Code
- EGWDryer, Film, Radiographic2Product Code
- EGYProcessor, Radiographic-Film, Automatic, Dental2Product Code
- HBKChair, Pneumoencephalographic2Product Code
- ITXTransducer, Ultrasonic, Diagnostic2Product Code
- ITYAssembly, Tube Housing, X-Ray, Diagnostic1Product Code
- IWNCassette, Measurement, Ardran-Crooks1Product Code
- IWYHolder, Head, Radiographic1Product Code
- IWZFilm, Radiographic1Product Code
- IXACassette, Radiographic Film2Product Code
- IXCIlluminator, Radiographic-Film1Product Code
- IXDSource, Calibration, Sealed, Nuclear1Product Code
- IXFTest-Pattern, Radiographic1Product Code
- IXGPhantom, Anthropomorphic, Radiographic1Product Code
- IXHCamera, Focal Spot, Radiographic1Product Code
- IXJGrid, Radiographic1Product Code
- IXKSystem, Imaging, X-Ray, Electrostatic2Product Code
- IXLDevice, Spot-Film2Product Code
- IXOSynchronizer, Ecg / Respirator, Radiographic1Product Code
- IXQTable, Radiographic, Stationary Top2Product Code
- IXRTable, Radiographic, Tilting2Product Code
- IXWProcessor, Radiographic-Film, Automatic2Product Code
- IXXProcessor, Cine Film2Product Code
- IXYHolder, Radiographic Cassette, Wall-Mounted1Product Code
- IYBTube Mount, X-Ray, Diagnostic1Product Code
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2Product Code
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- K241069iLoop Interventional Coil 0.55T2Cleared 510(K)
- K233652Contour Hand/Wrist (Q7000232)2Cleared 510(K)
- K233656Contour Shoulder2Cleared 510(K)
- K233600Smart Fit Knee 3.0T2Cleared 510(K)
- K233444InkSpace Imaging Small Body Array2Cleared 510(K)
- K23334816 Breast Coil2Cleared 510(K)
- K232762dS Breast Coil 7ch 1.5T2Cleared 510(K)
- K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T2Cleared 510(K)
- K2310851.5T HD T/R Knee Array (10-F34127)2Cleared 510(K)
- K223484IGAR System (1001.A)2Cleared 510(K)
- K231647XENOVIEW 3.0T Chest Coil2Cleared 510(K)
- K2232258ch T/R Knee Coil2Cleared 510(K)
- K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil2Cleared 510(K)
- K223429Contour Knee2Cleared 510(K)
- K2233783.0T 16ch AIR AA2Cleared 510(K)
- K212239XENOVIEW 3.0T Chest Coil2Cleared 510(K)
- K223487InkSpace Imaging Body Array2Cleared 510(K)
- K2232398ch Wrist Coil2Cleared 510(K)
- K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil2Cleared 510(K)
- K2223258ch Wrist Coil2Cleared 510(K)
- K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil2Cleared 510(K)
- K213735dS Sentinelle Breast 16ch 1.5T Coil2Cleared 510(K)
- K213727dS Sentinelle Breast 16ch 3.0T Coil2Cleared 510(K)
- K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T2Cleared 510(K)
- K21368732Ch 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 16ch2Cleared 510(K)
- K211658OR 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 3T2Cleared 510(K)
- K213766dS 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 3.0T2Cleared 510(K)
- K213397InkSpace Imaging Pediatric Body Array2Cleared 510(K)
- K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T2Cleared 510(K)
- K213351ds Head 32ch 3.0T2Cleared 510(K)
- K2008368ch Flex Suite2Cleared 510(K)
- K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil2Cleared 510(K)
- K200477Flex Body Speeder2Cleared 510(K)
- K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support2Cleared 510(K)
- K193140Flex Body SPEEDER2Cleared 510(K)
- K190668Encompass 15 Channel Head Coil, 3T2Cleared 510(K)
- K1827373T 32 Channel Head Coil2Cleared 510(K)
- K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 242Cleared 510(K)
- K183111Contour 242Cleared 510(K)
- K1829581.5T 16ch Breast Coil2Cleared 510(K)
- K1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil2Cleared 510(K)
- K1825901.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA2Cleared 510(K)
- K1825043.0T Air MP M, 3.0T Air MP L2Cleared 510(K)
- K18169716ch Foot/ Ankle SPEEDER2Cleared 510(K)
- K18066648CH Head Coil2Cleared 510(K)
- K163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil2Cleared 510(K)
- K180123Breast BI 7 MR Coil 1.5T Mammavention2Cleared 510(K)
- K17346916ch T/R Hand Wrist Coil2Cleared 510(K)
- K1722228ch Flex Suite2Cleared 510(K)
- K1733773.0T 16ch Breast Coil2Cleared 510(K)
- K173290DuoFLEX Coil Suite2Cleared 510(K)
- K172695AIR Anterior Array, AIR Posterior Array2Cleared 510(K)
- K173446Contour 242Cleared 510(K)
- K171515NHAC 162Cleared 510(K)
- K162651Breast BI 7 MR Coil Mammavention 3T2Cleared 510(K)
- K16320548CH Head Coil2Cleared 510(K)
- K1629468ch Knee-Foot SPEEDER2Cleared 510(K)
- K16262316ch T/R Hand Wrist Coil2Cleared 510(K)
- K162966TxRx Knee 15 Flare MR Coil 1.5T2Cleared 510(K)
- K163066TxRx Knee 15 Flare MR Coil 3.0T2Cleared 510(K)
- K162863dS Small Extremity 16CH 1.5T Coil2Cleared 510(K)
- K16202916ch T/R Knee Coil2Cleared 510(K)
- K162079TRILLIUM Oval Head Coil 322Cleared 510(K)
- K162177dS FootAnkle I6CH 1.5T Coil2Cleared 510(K)
- K1620011.5T and 3.0T 16 CH GE Shoulder Coils2Cleared 510(K)
- K1609328ch Foot Ankle Coil2Cleared 510(K)
- K1609358ch Foot Ankle Coil2Cleared 510(K)
- K16119316ch Tx/Rx Knee SPEEDER2Cleared 510(K)
- K1526958 CH Knee SPEEDER2Cleared 510(K)
- K15175316 ch Tx/Rx Knee SPEEDER2Cleared 510(K)
- K1516538ch Foot Ankle Coil2Cleared 510(K)
- K151829Atlas SPEEDER Header/Neck2Cleared 510(K)
- K15033118ch T/R Knee Coil2Cleared 510(K)
- K1433893.0T GEM RT Open Array2Cleared 510(K)
- K142676Siemens 3.0T PROCURE Array Coil2Cleared 510(K)
- K142802Atlas SPEEDER Head/Neck2Cleared 510(K)
- K142755Siemens 3.0 Blanket Array Coil2Cleared 510(K)
- K142002BREAST SPEEDER CX, GRID HOLDER CX2Cleared 510(K)
- K133506NORAS OR HEAD HOLDER FLEXIBILITY2Cleared 510(K)
- K1418323T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE2Cleared 510(K)
- K140998PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL2Cleared 510(K)
- K1406061.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL2Cleared 510(K)
- K14025216 CH MULTIPURPOSE COIL VARIETY2Cleared 510(K)
- K140282ST SENSE NV 8 ARRAY COIL2Cleared 510(K)
- K1339861.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY2Cleared 510(K)
- K132444ATAMA SYSTEM2Cleared 510(K)
- K1334221.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE2Cleared 510(K)
- K130706DUOFLEX COIL SUITE (1.5T)2Cleared 510(K)
- K1304573T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL2Cleared 510(K)
- K123708SPINE COIL2Cleared 510(K)
- K1232721.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM2Cleared 510(K)
- K1236811.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL2Cleared 510(K)
- K1233271.5T GEM RT OPEN ARRAY2Cleared 510(K)
- K123091VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T2Cleared 510(K)
- K122897SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 8006452Cleared 510(K)
- K123492DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)2Cleared 510(K)
- K122646DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T2Cleared 510(K)
- K122694GE 8CH FOOT ANKLE COIL2Cleared 510(K)
- K122638TOSHIBA 3T 32CH HEAD SPEEDER COIL,2Cleared 510(K)
- K121910OCTAVE SPEEDER HEAD2Cleared 510(K)
- K121911OCTAVE SPEEDER SPINE2Cleared 510(K)
- K1213621.5T 16CH FLEX SPEEDER LARGE2Cleared 510(K)
- K121249MULTIARRAY KIT2Cleared 510(K)
- K120627TOSHIBA 1.5T QD HEAD COIL2Cleared 510(K)
- K113365INFANT ARRAY2Cleared 510(K)
- K1134741.5T GEM FLEX COIL2Cleared 510(K)
- K120290TOSHIBA 1.5T CARDIAC COIL2Cleared 510(K)
- K120122SENSE MSK S 8CH 1.5T2Cleared 510(K)
- K1116731.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL2Cleared 510(K)
- K113280CAROTID COIL GE 1.5T2Cleared 510(K)
- K112002CAROTID COIL2Cleared 510(K)
- K112293HTS EXTREMITY COIL, HTS SURFACE COIL2Cleared 510(K)
- K1123664CH FLEX SPEEDER2Cleared 510(K)
- K112313TOSHIBA 3T EXTRA LARGE KNEE COIL2Cleared 510(K)
- K111060MRGFUS PELVIC PA COIL MODEL 1.02Cleared 510(K)
- K111802SV BRAIN ARRAY, SIEMENS 3T2Cleared 510(K)
- K112112SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS2Cleared 510(K)
- K103274SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING2Cleared 510(K)
- K111259SV DBS VRAIN ARRAY2Cleared 510(K)
- K1112514CH FLEX SPEEDER2Cleared 510(K)
- K10274831P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T2Cleared 510(K)
- K110487FLEXIBLE CARDIAC COIL2Cleared 510(K)
- K110411ATAMA SYSTEM2Cleared 510(K)
- K110373TEMPOROMANIBULAR COIL 152Cleared 510(K)
- K1106101.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL2Cleared 510(K)
- K110591MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL2Cleared 510(K)
- K103335GEM OPTION FOR 1.5 MRI SYSTEMS2Cleared 510(K)
- K110120ECHELON RAPID CARDIAC COIL2Cleared 510(K)
- K103185TOSHIBA 1.5T EXTRA LARGE KNEE COIL2Cleared 510(K)
- K1035061.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)2Cleared 510(K)
- K103365DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A2Cleared 510(K)
- K103275SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS2Cleared 510(K)
- K1031491.5T 16-CHANNEL HAND-WRIST COIL2Cleared 510(K)
- K1033423.0T METAFLEXCOIL2Cleared 510(K)
- K10234831P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T2Cleared 510(K)
- K102889HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON2Cleared 510(K)
- K0936891.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS2Cleared 510(K)
- K10014114-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA2Cleared 510(K)
- K101632METAFLEXCOIL2Cleared 510(K)
- K091047NEONATE ARRAY COILS2Cleared 510(K)
- K101949PEDIATRIC BODY-CARDIAC COIL, MODEL: 50000126012Cleared 510(K)
- K101858PEDIATRIC HEAD-SPINE COIL (MODEL:50000127012Cleared 510(K)
- K1014928 CHANNEL CARDIAC PHASED ARRAY COIL2Cleared 510(K)
- K100113VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-512Cleared 510(K)
- K100670S-SCAN, MODEL 98000200102Cleared 510(K)
- K0938421.5T AND 3.0T GENERAL PURPOSE FLEX COILS2Cleared 510(K)
- K0932841.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL2Cleared 510(K)
- K093667SHOULDER SPEEDER COIL2Cleared 510(K)
- K093693NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH2Cleared 510(K)
- K0933483.0T 16 CHANNEL HEAD NECK SPINE COIL2Cleared 510(K)
- K092962CAROTID COIL 50000049012Cleared 510(K)
- K0919021.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 8004842Cleared 510(K)
- K091546NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI72302Cleared 510(K)
- K091114TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL2Cleared 510(K)
- K083539INFANT CARDIAC ARRAY2Cleared 510(K)
- K090267SV DBS BRAIN ARRAY, MODEL 1500SV-SMS642Cleared 510(K)
- K083541NEONATE HEAD AND BODY COILS2Cleared 510(K)
- K083578NORAS CPC MULTIFUNCTIONAL COIL2Cleared 510(K)
- K083166SPECIALTY COILS FOR THE MAGNETOM ESSENZA2Cleared 510(K)
- K083434TT1 GENERAL PURPOSE COIL2Cleared 510(K)
- K083086ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)2Cleared 510(K)
- K08325516CH AI BREAST COILS 1.5 T AND 3 T2Cleared 510(K)
- K0831601.5T ATLAS SPEEDER HEAD-NECK COIL2Cleared 510(K)
- K082987HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL2Cleared 510(K)
- K083014ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A2Cleared 510(K)
- K082916HRB-127-32 HIGH RESOLUTION BRAIN COIL2Cleared 510(K)
- K082636TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T2Cleared 510(K)
- K082373NORAS MR-BI320-PA 3T2Cleared 510(K)
- K081745ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL2Cleared 510(K)
- K081340PEDIATRIC BODY AND CARDIAC COIL, MODEL 010001402012Cleared 510(K)
- K081322MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL2Cleared 510(K)
- K081198ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N2Cleared 510(K)
- K081118NORAS MR-BI320-PA 1.5T2Cleared 510(K)
- K080820TEM 3002G- HN DUAL TUNE HEAD COIL2Cleared 510(K)
- K080120HFO SHOULDER COIL2Cleared 510(K)
- K080062OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-1202Cleared 510(K)
- K073310OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL2Cleared 510(K)
- K073131MICROMRI WRIST COIL2Cleared 510(K)
- K073236NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE2Cleared 510(K)
- K073181NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL2Cleared 510(K)
- K072874LBS-127-16 BREAST ARRAY COIL2Cleared 510(K)
- K072873LBS-63-16 BREAST ARRAY COIL2Cleared 510(K)
- K072935SPEEDER 1.5T WRIST ARRAY COIL2Cleared 510(K)
- K0729091.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL2Cleared 510(K)
- K072931MC 3003G-32R HEAD COIL2Cleared 510(K)
- K0719661.5T MRGFUS PELVIC COIL2Cleared 510(K)
- K071847MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL2Cleared 510(K)
- K071882MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,2Cleared 510(K)
- K071534CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS2Cleared 510(K)
- K071611NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL2Cleared 510(K)
- K071179NORAS OR HEAD HOLDER2Cleared 510(K)
- K071311NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL2Cleared 510(K)
- K070778NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL2Cleared 510(K)
- K070629FLEX AND LOOP COIL SET 1.5 T2Cleared 510(K)
- K063513ECHELON MR-RCC-150 CARDIAC COIL2Cleared 510(K)
- K063342MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS2Cleared 510(K)
- K063373FLEX LOOP COIL SET 3T2Cleared 510(K)
- K062767CTL-63 AND CTL-128 SPINE ARRAY COILS2Cleared 510(K)
- K062556ECHELON SHOULDER COIL2Cleared 510(K)
- K061950HHF1 ECHELON MULTI-PURPOSE COIL2Cleared 510(K)
- K061952CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-162Cleared 510(K)
- K061715MRGFUS GENERAL PURPOSE AND BREAST COIL2Cleared 510(K)
- K061281INSIGHT HEAD COIL2Cleared 510(K)
- K0611703.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE30002Cleared 510(K)
- K060758OR HEAD COIL 1.5 T2Cleared 510(K)
- K060873VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS2Cleared 510(K)
- K0606891.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL2Cleared 510(K)
- K060547ACCESS BREAST COIL 4/SMS2Cleared 510(K)
- K060401MEDRAD 3.0T ECOIL IMAGING SYSTEM2Cleared 510(K)
- K053042MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE2Cleared 510(K)
- K053017MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS2Cleared 510(K)
- K052916USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY2Cleared 510(K)
- K052704MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE2Cleared 510(K)
- K052827MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS2Cleared 510(K)
- K052497NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A2Cleared 510(K)
- K0526211.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL2Cleared 510(K)
- K0525841.5T 12 CHANNEL BODY ARRAY2Cleared 510(K)
- K0525853T HD BREAST ARRAY2Cleared 510(K)
- K052045ACCESS BREAST COIL2Cleared 510(K)
- K052200TEM 3000 HEAD COIL2Cleared 510(K)
- K052077G-SCAN CERVICAL SPINE COIL2Cleared 510(K)
- K051618SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-642Cleared 510(K)
- K051763QD KNEE/FOOT COIL, MODEL MJQJ-147A2Cleared 510(K)
- K051512CAC-127-8 CARDOAC ARRAY COIL2Cleared 510(K)
- K050728OPEN BREAST COIL (OBC) WITH BIOPSY PLATES2Cleared 510(K)
- K0513493.0T PROSTATE IMAGING SYSTEM2Cleared 510(K)
- K050622HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL2Cleared 510(K)
- K050621NVA-127-8-A NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K050514MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS2Cleared 510(K)
- K050476CORDLESS COIL2Cleared 510(K)
- K050307AIRIS ELITE RAPID BODY COIL2Cleared 510(K)
- K050299HRK-123 KNEE ARRAY COIL2Cleared 510(K)
- K04271813C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA2Cleared 510(K)
- K04261731P/1H HEADCOIL FOR MAGNETOM ALLEGRA2Cleared 510(K)
- K042844GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL2Cleared 510(K)
- K042342MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL2Cleared 510(K)
- K04220711000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL2Cleared 510(K)
- K0421863.0T 8-CHANNEL CTL SPINE ARRAY2Cleared 510(K)
- K042103NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K042009MARK III PHASED ARRAY SHOULDER COIL2Cleared 510(K)
- K041921GE SIGNA PROFILE 6 INCH GP COIL2Cleared 510(K)
- K041481MODEL BBC-127 BIOPSY BREAST COIL2Cleared 510(K)
- K041487QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT2Cleared 510(K)
- K041185TORSO ARRAY COIL, MODEL 558GE-642Cleared 510(K)
- K041145MODIFICATION TO E-SCAN XQ MRI SYSTEM2Cleared 510(K)
- K040937TEM 3000 HEAD COIL2Cleared 510(K)
- K040122MAYO CLINIC BC-10 3.0T2Cleared 510(K)
- K040640MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL2Cleared 510(K)
- K040349MODIFICATION TO HRW-127 WRIST ARRAY COIL2Cleared 510(K)
- K040348MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K040288QSC-127-INT SHOULDER ARRAY COIL SET2Cleared 510(K)
- K033662SYNERGY SPINE ARRAY COIL2Cleared 510(K)
- K033490SPIRIT 5000 CARDIAC COIL2Cleared 510(K)
- K033753PELVIC ARRAY COIL2Cleared 510(K)
- K033235GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL2Cleared 510(K)
- K033292AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-122Cleared 510(K)
- K033567MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS2Cleared 510(K)
- K033353MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES2Cleared 510(K)
- K032576BIOPSY BREAST COIL, MODEL BBC2Cleared 510(K)
- K033152HAC-12 AND HAC-30 HEAD ARRAY COIL2Cleared 510(K)
- K033151KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL2Cleared 510(K)
- K032633HRK-63-8 KNEE ARRAY COIL2Cleared 510(K)
- K0326183.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL2Cleared 510(K)
- K0325383.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL2Cleared 510(K)
- K0324743.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL2Cleared 510(K)
- K032415MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL2Cleared 510(K)
- K032429QSC-127 SHOULDER ARRAY COIL SET2Cleared 510(K)
- K032090NEUROVASCULAR ARRAY COIL, MODEL NVA-127-82Cleared 510(K)
- K0320458 CHANNEL CARDIAC PHASED ARRAY COIL2Cleared 510(K)
- K031536BRAIN COIL, MODEL 9900GE-642Cleared 510(K)
- K031365PRIMA III TOTALSENSE TORSO COIL2Cleared 510(K)
- K031119MAYO CLINIC BC-10 1.5T2Cleared 510(K)
- K031366PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL2Cleared 510(K)
- K031095SENSE BODY COIL2Cleared 510(K)
- K031172SPIRIT III TOTALSENSE CARDIAC COIL2Cleared 510(K)
- K031143ALPHA 5000 WRIST COIL2Cleared 510(K)
- K031139PREMIER III PHASED ARRAY CTL SPINE COIL2Cleared 510(K)
- K031209GE 1.5T 8 CHANNEL TORSO COIL2Cleared 510(K)
- K031089GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY2Cleared 510(K)
- K031056MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL2Cleared 510(K)
- K030371PRIMA III TOTALSENSE TORSO COIL2Cleared 510(K)
- K030540HTS ARRAY COIL2Cleared 510(K)
- K030953GE 3.0T GENERAL PURPOSE FLEX COIL2Cleared 510(K)
- K030317MODEL 1300GE-64: PEDIATRIC POSITIONER2Cleared 510(K)
- K0304953.0T TORSO PHASED ARRAY COIL2Cleared 510(K)
- K030042PREMIER III PHASED ARRAY CTL SPINE COIL2Cleared 510(K)
- K023982LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL2Cleared 510(K)
- K023929MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K023848MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:2Cleared 510(K)
- K024187SPIRIT III TOTALSENSE CARDIAC COIL2Cleared 510(K)
- K022863HTS COIL2Cleared 510(K)
- K023650INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL2Cleared 510(K)
- K024352HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM2Cleared 510(K)
- K024354PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS2Cleared 510(K)
- K024209QWH-250-PAN WRIST ARRAY COIL2Cleared 510(K)
- K024208OBC-250-PAN BREAST ARRAY COIL2Cleared 510(K)
- K023247CHAMPION 5000 PERIPHERAL VASCULAR COIL2Cleared 510(K)
- K023084MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL2Cleared 510(K)
- K0235716 CHANNEL BODY COIL2Cleared 510(K)
- K023679GORE 3.0T TORSO ARRAY2Cleared 510(K)
- K023596MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL2Cleared 510(K)
- K023442EXTRA LARGE BODY COIL2Cleared 510(K)
- K022007LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES2Cleared 510(K)
- K022582EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL2Cleared 510(K)
- K023164BBC-63-GE BREAST ARRAY COIL2Cleared 510(K)
- K022910QSC-63-INT SHOULDER ARRAY COIL SET2Cleared 510(K)
- K022883HRK-63 KNEE ARRAY COIL2Cleared 510(K)
- K022720CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL2Cleared 510(K)
- K0226698 CHANNEL CARDIAC PHASED ARRAY COIL2Cleared 510(K)
- K022588HRW-63-INT WRIST ARRAY COIL2Cleared 510(K)
- K022488MODEL OBC-63 BREAST ARRAY COIL2Cleared 510(K)
- K022487MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL2Cleared 510(K)
- K021751ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K0223951.5T SCANMED PV ARRAY2Cleared 510(K)
- K022372HRH-127-8 HEAD ARRAY COIL2Cleared 510(K)
- K021631ISA-21 INTERVENTIONAL SPINE ARRAY COIL2Cleared 510(K)
- K021330MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL2Cleared 510(K)
- K021141MILLENNIUM 5000 MEUROVASCULAR COIL2Cleared 510(K)
- K021433MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL2Cleared 510(K)
- K021575OBC-127 BREAST ARRAY COIL2Cleared 510(K)
- K021570HNC-127-TRIO NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K020850GPF-29 GENERAL PURPOSE COIL SET2Cleared 510(K)
- K021262MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL2Cleared 510(K)
- K020993ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)2Cleared 510(K)
- K020790INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL2Cleared 510(K)
- K020601FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL2Cleared 510(K)
- K020495INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL2Cleared 510(K)
- K020606NVA-63-8 NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K013854MARK 5000 QUADRATURE SHOULDER COIL2Cleared 510(K)
- K014086CTL BODY / SPINE ARRAY COIL2Cleared 510(K)
- K020036EXS-63 SMALL EXTREMITY ARRAY COIL2Cleared 510(K)
- K013985MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX2Cleared 510(K)
- K013594BODY ARRAY COIL2Cleared 510(K)
- K013595PREMIER III PHASED ARRAY CTL SPINE COIL2Cleared 510(K)
- K013894TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T2Cleared 510(K)
- K013592EXTREMITY COIL2Cleared 510(K)
- K013514PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL2Cleared 510(K)
- K013541SHOULDER COIL2Cleared 510(K)
- K013528CRYSTAL 5000 PHASES ARRAY TMJ COIL2Cleared 510(K)
- K011683NURVO 9000 ENDOCAVITARY COILS2Cleared 510(K)
- K013810CARDIOVASCULAR ARRAY2Cleared 510(K)
- K013602HNC-63-INT NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K013508HRH-127-ALLEGRA HEAD ARRAY COIL2Cleared 510(K)
- K012491MACHNET CAROTIDS COIL ARRAY ASSEMBLY2Cleared 510(K)
- K013322HAC-420 HEAD ARRAY COIL2Cleared 510(K)
- K013159HRH-63-8 HEAD ARRAY COIL2Cleared 510(K)
- K013099MODIFICATION TO: QWH-420 WRIST ARRAY COIL2Cleared 510(K)
- K011781INTERCEPT-URETHRAL MICROCOIL2Cleared 510(K)
- K012728E-SCAN MRI SYSTEM2Cleared 510(K)
- K012353HNC-127 NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K011608MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL2Cleared 510(K)
- K010802CARDIAC VIEW, MODEL 20012Cleared 510(K)
- K010946MARK 9000 PHASED ARRAY SHOULDER COIL2Cleared 510(K)
- K003505KFA-127 KNEE, FOOT AND ANKLE ARRAY2Cleared 510(K)
- K010513CARDIAC VIEW, MODEL 20012Cleared 510(K)
- K010730MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL2Cleared 510(K)
- K010074MODEL 455GE PHASED ARRAY WRIST COIL2Cleared 510(K)
- K0036133.0.T SIGNA VH/I (T/R) BODY IMAGING COIL2Cleared 510(K)
- K003946SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL2Cleared 510(K)
- K010140HRH-127 HEAD ARRAY COIL2Cleared 510(K)
- K003655PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL2Cleared 510(K)
- K003436SURGI-VISION GUIDEWIRE COIL2Cleared 510(K)
- K001097ACTIVE ARRAY CATHETER, MODEL CS-20002Cleared 510(K)
- K003386SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-642Cleared 510(K)
- K003097BRAIN COIL, MODEL 9800GE-642Cleared 510(K)
- K003685MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL2Cleared 510(K)
- K003366MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL2Cleared 510(K)
- K003144MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL2Cleared 510(K)
- K002916SURGI-VISION PROSTATE COIL2Cleared 510(K)
- K002860MODEL 6900GE-64: C-SPINE ARRAY2Cleared 510(K)
- K002864MODEL 6600GE-64: TRAMA NECK ARRAY2Cleared 510(K)
- K002774HRH-63 HEAD ARRAY COIL2Cleared 510(K)
- K003340OBC-149 BREAST ARRAY COIL2Cleared 510(K)
- K003331QWH-149 WRIST ARRAY COIL2Cleared 510(K)
- K002522OPART, MODEL MRT-6002Cleared 510(K)
- K002483POWER 5000 GENERAL PURPOSE COIL2Cleared 510(K)
- K002482VISION 9000 PHASED ARRAY TORSO COIL2Cleared 510(K)
- K002345SURGI-VISION URETHRAL COIL2Cleared 510(K)
- K002602OBC-63 MEBREAST ARRAY COIL2Cleared 510(K)
- K002539OBC-096 BREAST ARRAY COIL2Cleared 510(K)
- K001946NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K001944HAC-300 HEAD ARRAY COIL2Cleared 510(K)
- K001870MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL2Cleared 510(K)
- K001582LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE2Cleared 510(K)
- K001312MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL2Cleared 510(K)
- K001303BREAST IMMOBILIZATION DEVICE MR-BY 1602Cleared 510(K)
- K001713HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA2Cleared 510(K)
- K001331SYNERGY HEAD/NECK COIL2Cleared 510(K)
- K001210HI-RES 9000 PHASED ARRAY CAROTID COIL2Cleared 510(K)
- K001209INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL2Cleared 510(K)
- K000993LIBERTY 9000 BREAST COIL2Cleared 510(K)
- K000549OPART, MODEL MRT-6002Cleared 510(K)
- K000437INTERVENTIONAL BODY COIL2Cleared 510(K)
- K000345MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES2Cleared 510(K)
- K000935KFA-63 KNEE AND FOOT ARRAY2Cleared 510(K)
- K000589MODEL 445SI-64E QUADRATURE WRIST COIL2Cleared 510(K)
- K994436SURGI-VISION ESOPHAGEAL STYLET COIL2Cleared 510(K)
- K994378AIRIS II2Cleared 510(K)
- K000002MAGNA 5000 PHASED ARRAY CTL SPINE COIL2Cleared 510(K)
- K994345MAGNA 5000 PHASED ARRAY CTL SPINE COIL2Cleared 510(K)
- K994315CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM2Cleared 510(K)
- K993898KAC-63 KNEE ARRAY COIL2Cleared 510(K)
- K994042SHARP 9000 PHASED ARRAY BRAIN COIL2Cleared 510(K)
- K994040PHASED ARRAY KNEE AND FOOT COIL2Cleared 510(K)
- K993819QWH-300 WRIST ARRAY COIL2Cleared 510(K)
- K993776OBC-300 BREAST ARRAY COIL2Cleared 510(K)
- K993780QSC-300 SHOULDER ARRAY COILS2Cleared 510(K)
- K993719KAC-300 KNEE ARRAY COIL2Cleared 510(K)
- K993477HRW WRIST ARRAY COIL2Cleared 510(K)
- K993279QSC-085 SHOULDER ARRAY COIL2Cleared 510(K)
- K993235QWH-085 WRIST ARRAY COIL2Cleared 510(K)
- K993233OBC-085 BREAST ARRAY COIL2Cleared 510(K)
- K992650AIRIS, AIRIS II2Cleared 510(K)
- K992193ENDO-ESOPHAGEAL MR COIL2Cleared 510(K)
- K991765SYNERGY SHOULDER COIL2Cleared 510(K)
- K991740OPART, MODEL MRT-6002Cleared 510(K)
- K991724QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-642Cleared 510(K)
- K991434QUADRATURE WRIST COIL, MODEL 445PH-642Cleared 510(K)
- K991113`INEAR WRIST COIL, MODEL 440GE-092Cleared 510(K)
- K991115LINEAR SHOULDER COIL, MODEL 414GE-092Cleared 510(K)
- K991057EXTRA LARGE BODY COIL FOR OPART (MRT-600)2Cleared 510(K)
- K990007OPART, MODEL MRT-6002Cleared 510(K)
- K983139SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL2Cleared 510(K)
- K984588PHASED ARRAY FLEXIBLE CARDIAC COIL2Cleared 510(K)
- K984257MEDRAD PHASED ARRAY NEUROVASCULAR COIL2Cleared 510(K)
- K984159MEDRAD QUADRATURE CTL ARRAY COIL2Cleared 510(K)
- K984272MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-50002Cleared 510(K)
- K984278MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II2Cleared 510(K)
- K982978MODEL 340GE-21C QUADRATURE BRAIN COIL2Cleared 510(K)
- K983143MARK 5000 PHASED ARRAY SHOULDER COIL2Cleared 510(K)
- K982972SIGNA PROFILE SMALL HEAD COIL2Cleared 510(K)
- K982921MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA2Cleared 510(K)
- K982919MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC2Cleared 510(K)
- K982916MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC2Cleared 510(K)
- K982772SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL2Cleared 510(K)
- K983222PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-642Cleared 510(K)
- K983109MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY2Cleared 510(K)
- K982496QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D2Cleared 510(K)
- K982339FLOW 7000 PERIPHERAL VASCULAR COIL2Cleared 510(K)
- K981959OUTLOOK LARGE PHASED ARRAY NECK COIL2Cleared 510(K)
- K981406CERVIX COIL LATEX SHEATH2Cleared 510(K)
- K981094MEDRAD NEUROVASCULAR COIL2Cleared 510(K)
- K980691AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K974438MEDRAD ATD-T INTERFACE DEVICE2Cleared 510(K)
- K980157PREMIER 7000 CTL SPINE COIL2Cleared 510(K)
- K974308MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY2Cleared 510(K)
- K973787MEDRAD 1.5T EXTREMITY ARRAY2Cleared 510(K)
- K973630CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM2Cleared 510(K)
- K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)2Cleared 510(K)
- K972296MAGNETIC RESONANCE DIAGNOSTIC SYSTEM2Cleared 510(K)
- K972205ALPHA 7000 QUADRATURE WRIST COIL2Cleared 510(K)
- K972340INSIGHT 7000 PHASED ARRAY TORSO COIL2Cleared 510(K)
- K971667CARDIAC PHASED ARRAY COIL2Cleared 510(K)
- K964969SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)2Cleared 510(K)
- K971246LEO 7000 QUADRATURE KNEE COIL2Cleared 510(K)
- K971016MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)2Cleared 510(K)
- K970868MODEL HNC NEUROVASCULAR ARRAY COIL2Cleared 510(K)
- K964820MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A2Cleared 510(K)
- K964813MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:2Cleared 510(K)
- K964668MODELS EXL AND EXS EXTREMITY COIL SET2Cleared 510(K)
- K964854MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL2Cleared 510(K)
- K964678PHASED ARRAY NECK COIL2Cleared 510(K)
- K964141GE STERILE DISPOSABLE EQUIPMENT COIL COVER2Cleared 510(K)
- K963356PHASED ARRAY SHOULDER COIL2Cleared 510(K)
- K961628MINI FLEX COIL2Cleared 510(K)
- K961525ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)2Cleared 510(K)
- K961391FLEXART QD HEAD/NECK COIL2Cleared 510(K)
- K954952MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL2Cleared 510(K)
- K955626MEDRAD/HITACHI BREAST IMAGING SURFACE COIL2Cleared 510(K)
- K954190MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL2Cleared 510(K)
- K953595MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K952944MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL2Cleared 510(K)
- K950966MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE2Cleared 510(K)
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2Product Code
- MUABone Sonometer2Product Code
- MUEFull Field Digital, System, X-Ray, Mammographic2Product Code
- MUIMedia, Coupling, Ultrasound2Product Code
- MWPCabinet, X-Ray System2Product Code
- MYNAnalyzer, Medical Image2Product Code
- NCSSystem, Imaging, Holography, Acoustic2Product Code
- NWEColon Computed Tomography System, Computer Aided Detection2Product Code
- OASX-Ray, Tomography, Computed, Dental2Product Code
- OEBLung Computed Tomography System, Computer-Aided Detection2Product Code
- OIIArthrogram Tray2Product Code
- OIJBiopsy Needle Guide Kit2Product Code
- OIKRadiology Dental Tray2Product Code
- OILDiscography Kit2Product Code
- OIMMri Disposable Kit2Product Code
- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
- OQQDiagnostic Ultrasonic Transducer, Robotic2Product Code
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2Product Code
- OWBInterventional Fluoroscopic X-Ray System2Product Code
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QFMRadiological Computer-Assisted Prioritization Software For Lesions2Product Code
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2Product Code
- QHXFluoroscopic X-Ray Image Intensifier1Product Code
- QHYSolid State Fluoroscopic X-Ray Imager2Product Code
- QIHAutomated Radiological Image Processing Software2Product Code
- QKBRadiological Image Processing Software For Radiation Therapy2Product Code
- RCCC-Arm Fluoroscopic X-Ray System2Product Code
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2Product Code
- QXLCabinet, Emission Computed Tomography System2Product Code
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
InkSpace Imaging Pediatric Body Array
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213397
- 510(k) Type
- Traditional
- Applicant
- InkSpace Imaging, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/17/2021
- Days to Decision
- 60 days
- Submission Type
- Summary