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
- K253182InkSpace Imaging Small Body Array (SBA12PH30x)2Cleared 510(K)
- K243428e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector2Cleared 510(K)
- K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)2Cleared 510(K)
- K243675InkSpace Imaging Small Body Array2Cleared 510(K)
- K243316XENOVIEW 3.0T Chest Coil2Cleared 510(K)
- K243033dS Wrist coil 8ch 1.5T2Cleared 510(K)
- K242879dS Knee Coil 8ch 1.5T2Cleared 510(K)
- K242096dS FootAnkle Coil 8ch 1.5T2Cleared 510(K)
- 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)
- K121911OCTAVE SPEEDER SPINE2Cleared 510(K)
- K121910OCTAVE SPEEDER HEAD2Cleared 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)
- K072873LBS-63-16 BREAST ARRAY COIL2Cleared 510(K)
- K072874LBS-127-16 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)
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- K022007LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES2Cleared 510(K)
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- K013894TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T2Cleared 510(K)
- K013592EXTREMITY COIL2Cleared 510(K)
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- K013541SHOULDER COIL2Cleared 510(K)
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- K982916MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC2Cleared 510(K)
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- K973787MEDRAD 1.5T EXTREMITY ARRAY2Cleared 510(K)
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- K964820MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A2Cleared 510(K)
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- K964854MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL2Cleared 510(K)
- K964678PHASED ARRAY NECK COIL2Cleared 510(K)
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- K963356PHASED ARRAY SHOULDER COIL2Cleared 510(K)
- K961628MINI FLEX COIL2Cleared 510(K)
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- 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)
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- MUIMedia, Coupling, Ultrasound2Product Code
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- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2Product 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
- QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence2Product 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
- SFVX-Ray, Computed Tomography, Cone-Beam2Product 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
AIRIS II
- Page Type
- Cleared 510(K)
- 510(k) Number
- K994378
- 510(k) Type
- Traditional
- Applicant
- HITACHI MEDICAL SYSTEMS AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/7/2000
- Days to Decision
- 71 days
- Submission Type
- Summary