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
- K252371uMR 6802Cleared 510(K)
- K251386ECHELON Synergy2Cleared 510(K)
- K251399SIGNA™ Sprint2Cleared 510(K)
- K251682MuscleView 2.02Cleared 510(K)
- K251029Vista OS, Vista AI Scan, RTHawk2Cleared 510(K)
- K252239InVision™ 3T Recharge Operating Suite2Cleared 510(K)
- K250246uMR Jupiter2Cleared 510(K)
- K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K243547uMR Ultra2Cleared 510(K)
- K243397uMR 6802Cleared 510(K)
- K251808Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems2Cleared 510(K)
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile2Cleared 510(K)
- K250436MAGNETOM Flow.Ace; MAGNETOM Flow.Plus2Cleared 510(K)
- K243667Sonic DL2Cleared 510(K)
- K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System2Cleared 510(K)
- K250236Swoop® Portable MR Imaging® System (V2)2Cleared 510(K)
- K251276Swoop® Portable MR Imaging® System2Cleared 510(K)
- K243122uMR Omega2Cleared 510(K)
- K250379SIGNA Prime Elite2Cleared 510(K)
- K242006SureWave Elastography (Q7000225)2Cleared 510(K)
- K242825Prenuvo Body Composition2Cleared 510(K)
- K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K242573NIDO Baby Magnetic Resonance Imaging System2Cleared 510(K)
- K242524SyMRI2Cleared 510(K)
- K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)2Cleared 510(K)
- K241242SIGNA MAGNUS2Cleared 510(K)
- K241925VitruvianScan (v1.0)2Cleared 510(K)
- K241331MuscleView2Cleared 510(K)
- K241607MyoStrain (6.0)2Cleared 510(K)
- K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K241429ECHELON Synergy MRI System2Cleared 510(K)
- K231133neo3152Cleared 510(K)
- K240944Swoop® Portable MR Imaging® System2Cleared 510(K)
- K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)2Cleared 510(K)
- K233629APERTO Lucent MRI System2Cleared 510(K)
- K233687ECHELON Synergy V10.02Cleared 510(K)
- K233673uMR Jupiter2Cleared 510(K)
- K240571OASIS MRI System2Cleared 510(K)
- K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K240744uMR 6802Cleared 510(K)
- K240608MAGNETOM Viato.Mobile2Cleared 510(K)
- K233733SyMRI2Cleared 510(K)
- K240540uMR Omega2Cleared 510(K)
- K232322MAGNETOM Terra; MAGNETOM Terra.X2Cleared 510(K)
- K232765MAGNETOM Cima.X Fit2Cleared 510(K)
- K240157InVision™ 1.5 Surgical Theatre2Cleared 510(K)
- K232644neuro42 MRI System2Cleared 510(K)
- K233728SIGNA Champion2Cleared 510(K)
- K232535MAGNETOM Sola; MAGNETOM Altea2Cleared 510(K)
- K231587MAGNETOM Cima.X2Cleared 510(K)
- K232680fMRI Hardware System2Cleared 510(K)
- K232494MAGNETOM Avanto fit; MAGNETOM Skyra fit2Cleared 510(K)
- K231617MAGNETOM Free.Max; MAGNETOM Free.Star2Cleared 510(K)
- K232346Digital Expert Access with Remote Scanning2Cleared 510(K)
- K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit2Cleared 510(K)
- K232981Synq Software Version 1.32Cleared 510(K)
- K232760Swoop® Portable MR Imaging System®2Cleared 510(K)
- K230187Terran NM-1012Cleared 510(K)
- K232482MAGNETOM Viato.Mobile2Cleared 510(K)
- K232361Promaxo MRI System II2Cleared 510(K)
- K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K232030Ingenia Elition R5.7.1 SP4 MR Systems2Cleared 510(K)
- K223426ECHELON Synergy MRI system2Cleared 510(K)
- K231459HepaFatSmart (V2.0.0)2Cleared 510(K)
- K223523Sonic DL2Cleared 510(K)
- K230152uMR Omega2Cleared 510(K)
- K230758uMR 5702Cleared 510(K)
- K230972Ingenia Elition and MR 7700 MR Systems2Cleared 510(K)
- K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems2Cleared 510(K)
- K223343MAGNETOM Amira; MAGNETOM Sempra2Cleared 510(K)
- K223875MOBINEURO Alita Intraoperative MRI System2Cleared 510(K)
- K2232031.5T 24E Posterior Array2Cleared 510(K)
- K213805MAGNETOM Vida2Cleared 510(K)
- K230208Swoop® Portable MR Imaging System™2Cleared 510(K)
- K222259NEONA 1.5T MRI System2Cleared 510(K)
- K222755uMR 6802Cleared 510(K)
- K223439SIGNA Victor2Cleared 510(K)
- K221619ECHELON Oval V6.2 MRI System2Cleared 510(K)
- K223442MR 5300 and MR 7700 R11 MR Systems2Cleared 510(K)
- K223247Swoop Portable MR Imaging System2Cleared 510(K)
- K223079Stage2Cleared 510(K)
- K220332uMR Omega with uWS-MR-MRS2Cleared 510(K)
- K222968Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit2Cleared 510(K)
- K213960LiverMultiScan v5 (LMSv5)2Cleared 510(K)
- K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K221785TCL3 Motion Tracking System2Cleared 510(K)
- K221923Swoop Portable MR Imaging System2Cleared 510(K)
- K203279Veuron-Brain-mN12Cleared 510(K)
- K221025i_ Field 1.5T Superconducting Magnetic Resonance Imaging System2Cleared 510(K)
- K220575MAGNETOM Free.Max, MAGNETOM Free.Star2Cleared 510(K)
- K221393Swoop Portable MR Imaging System2Cleared 510(K)
- K213717AIR Recon DL2Cleared 510(K)
- K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems2Cleared 510(K)
- K220589MAGNETOM Skyra Fit2Cleared 510(K)
- K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A2Cleared 510(K)
- K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K220335Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K220151MAGNETOM Avanto Fit2Cleared 510(K)
- K220425MAGNETOM Vida, MAGNETOM Sola2Cleared 510(K)
- K220018MR Elastography; MZEK-001A2Cleared 510(K)
- K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei2Cleared 510(K)
- K213693MAGNETOM Vida with syngo MR XA50A2Cleared 510(K)
- K213603SIGNA Artist Evo2Cleared 510(K)
- K212419Magnifico Open, Magnifico MSK2Cleared 510(K)
- K212271smart-sync2Cleared 510(K)
- K213668SIGNA Hero2Cleared 510(K)
- K211980SIGNA Prime2Cleared 510(K)
- K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K211983AMRA Profiler2Cleared 510(K)
- K212673MR 53002Cleared 510(K)
- K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System2Cleared 510(K)
- K203372SyMRI2Cleared 510(K)
- K211406OASIS MRI System2Cleared 510(K)
- K212233RTHawk, HeartVista Cardiac Package2Cleared 510(K)
- K212367IMRIS iMRI 3T V2Cleared 510(K)
- K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K211633Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K210415QSM software, QSMetric2Cleared 510(K)
- K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System2Cleared 510(K)
- K210611MAGNETOM Free.Max2Cleared 510(K)
- K210843STAGE2Cleared 510(K)
- K211037Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K211118SIGNA 7.0T2Cleared 510(K)
- K203451TCL3 Motion Tracking System2Cleared 510(K)
- K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea2Cleared 510(K)
- K210164Vantage Elan 1.5T, MRT-2020, V6.02Cleared 510(K)
- K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K202518Promaxo MRI System2Cleared 510(K)
- K203653MRI PPG Patient Cable2Cleared 510(K)
- K203553Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K192650i_Space 1.5T Superconducting Magnetic Resonance Imaging System2Cleared 510(K)
- K202767Vantage Orian 1.5T, MRT-1550, V6.02Cleared 510(K)
- K203280Hepatica v1 (Hepatica v1.0.0)2Cleared 510(K)
- K201039HepaFat-AI2Cleared 510(K)
- K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K202966SIGNA Architect2Cleared 510(K)
- K202030OASIS MRI System2Cleared 510(K)
- K201615SIGNA 7.0T2Cleared 510(K)
- K202170LiverMultiScan2Cleared 510(K)
- K202210Vantage Orian 1.5T, MRT-1550, V6.02Cleared 510(K)
- K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit2Cleared 510(K)
- K202238SIGNA Artist2Cleared 510(K)
- K201141FIRMM2Cleared 510(K)
- K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System2Cleared 510(K)
- K201616SyMRI2Cleared 510(K)
- K193097Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K201389Resoundant Acoustic Driver System2Cleared 510(K)
- K201540uMR5702Cleared 510(K)
- K193021Vantage Orian 1.5T, MRT-1550, V6.02Cleared 510(K)
- K193176uMR 7802Cleared 510(K)
- K200327Evry2Cleared 510(K)
- K200024uMR 5702Cleared 510(K)
- K193282SIGNA Premier2Cleared 510(K)
- K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems2Cleared 510(K)
- K193218Innovision Audio2Cleared 510(K)
- K192852MRI ECG Patient Cable2Cleared 510(K)
- K193200uMR Omega2Cleared 510(K)
- K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit2Cleared 510(K)
- K192574Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR2Cleared 510(K)
- K192506Vantage Galan 3T, MRT-3020, V6.02Cleared 510(K)
- K192496Magnetom Sola, Magnetom Altea and Magnetom Sola Fit2Cleared 510(K)
- K192851OASIS MRI System2Cleared 510(K)
- K192002Lucy Point-of-Care Magnetic Resonance Imaging Device2Cleared 510(K)
- K193324Motion Correction System2Cleared 510(K)
- K193102MRIaudio PREM System with MRIview2Cleared 510(K)
- K193116MRopen EVO2Cleared 510(K)
- K191032fMRI Hardware System2Cleared 510(K)
- K192690Upgrade Kit MR GUI PRO, MrJ 3300 Plus2Cleared 510(K)
- K183274RTHawk, HeartVista Cardiac Package2Cleared 510(K)
- K192426Signa Voyager, Signa Voyager Quantum2Cleared 510(K)
- K191662Vantage Orian 1.5T, MRT-1550, V4.52Cleared 510(K)
- K191050MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow2Cleared 510(K)
- K190524MRopen 0.5 T2Cleared 510(K)
- K190017LiverMultiScan (LMSv3)2Cleared 510(K)
- K191128Vantage Titan 3T, MRT-3010, V2.52Cleared 510(K)
- K191036SyMRI2Cleared 510(K)
- K190461Achieva 1.5T, 3.0T and Intera 1.5T MR Systems2Cleared 510(K)
- K190757MAGNETOM Avanto Fit2Cleared 510(K)
- K191157uMR 780, uMR 7902Cleared 510(K)
- K183657Vantage Galan 3T, MRT-3020/A9, V5.02Cleared 510(K)
- K183621EMMA 1.5T MRI System2Cleared 510(K)
- K190138MAGNETOM Aera2Cleared 510(K)
- K183222MAGNETOM Terra2Cleared 510(K)
- K183221MAGNETOM Amira, MAGNETOM Sempra2Cleared 510(K)
- K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems2Cleared 510(K)
- K182756MyoStrain 5.12Cleared 510(K)
- K183244MAGNETOM Lumina2Cleared 510(K)
- K183685O-Scan2Cleared 510(K)
- K183254Magnetom Vida2Cleared 510(K)
- K183231SIGNA Premier2Cleared 510(K)
- K183137uMR 580, uMR 5882Cleared 510(K)
- K173749AMRA Profiler2Cleared 510(K)
- K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D2Cleared 510(K)
- K182299MAGNETOM Aera2Cleared 510(K)
- K182282Vantage Orian 1.5T, MRT-1550, V4.52Cleared 510(K)
- K181433MAGNETOM Vida2Cleared 510(K)
- K182129MAGNETOM Sola2Cleared 510(K)
- K181322MAGNETOM Sola2Cleared 510(K)
- K181371uMR 7902Cleared 510(K)
- K181370uMR 7802Cleared 510(K)
- K181593Vantage Galan 3T, MRT-3020/A7, V5.02Cleared 510(K)
- K181479Ingenia Ambition S and Ingenia Ambition X2Cleared 510(K)
- K173507Prodiva 1.5T CX and Prodiva 1.5T CS R5.42Cleared 510(K)
- K180100MRIaudio PREM System2Cleared 510(K)
- K181093SyMRI2Cleared 510(K)
- K180925uMR 5702Cleared 510(K)
- K180926uMR 5602Cleared 510(K)
- K173079Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.42Cleared 510(K)
- K180592G-scan Brio2Cleared 510(K)
- K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBE2Cleared 510(K)
- K173451Ingenia Elition S and Ingenia Elition X2Cleared 510(K)
- K171778MR Wireless Gating System, Model WGS-1002Cleared 510(K)
- K173356Ingenia Elition S and Ingenia Elition X R5.42Cleared 510(K)
- K173224SPIN-SWI2Cleared 510(K)
- K173409Wireless Audio System2Cleared 510(K)
- K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit2Cleared 510(K)
- K173558SyMRI2Cleared 510(K)
- K173382Vantage Galan 3T, V4.62Cleared 510(K)
- K1729203D APT2Cleared 510(K)
- K172110ECHELON OVAL V6.0A MRI System2Cleared 510(K)
- K173600MAGNETOM Amira2Cleared 510(K)
- K172685LiverMultiScan2Cleared 510(K)
- K172878Vantage Titan 3T, MRT-3010/A7, M-Power GX2Cleared 510(K)
- K170840MAGNETOM Terra2Cleared 510(K)
- K162943SyMRI2Cleared 510(K)
- K171597Vantage Elan 1.5T, V4.02Cleared 510(K)
- K170978Embrace Neonatal MRI System2Cleared 510(K)
- K171128SIGNA Premier2Cleared 510(K)
- K170090RTHawk, HeartVista Cardiac Package2Cleared 510(K)
- K170396MAGNETOM Vida2Cleared 510(K)
- K170412Vantage Titan 1.5T, MRT-1510, M-Power GX2Cleared 510(K)
- K162722HyperSense2Cleared 510(K)
- K163192Comfort EC7102Cleared 510(K)
- K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist2Cleared 510(K)
- K163312MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software2Cleared 510(K)
- K163211MAGNETOM Sempra with syngo MR E11S2Cleared 510(K)
- K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.32Cleared 510(K)
- K162931Ingenia 1.5T CX and Ingenia 3.0T CX R5.32Cleared 510(K)
- K162940MultiBand SENSE2Cleared 510(K)
- K162183Vantage Galan 3T, MRT-3020, V4.02Cleared 510(K)
- K162102MAGNETOM Avantofit, MAGNETOM Skyrafit2Cleared 510(K)
- K162403HyperBand2Cleared 510(K)
- K161795MAGNETOM ESSENZA2Cleared 510(K)
- K161973G-scan Brio, S-scan2Cleared 510(K)
- K161567SIGNA Voyager2Cleared 510(K)
- K161397MAGiC2Cleared 510(K)
- K160632Vantage Titan 1.5T, MRT-1510, V3.6 Software2Cleared 510(K)
- K161238S-scan2Cleared 510(K)
- K153740RTHawk, HeartVista Cardiac Package2Cleared 510(K)
- K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T2Cleared 510(K)
- K160152Trillium Oval V 5.1 MRI System2Cleared 510(K)
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit2Cleared 510(K)
- K153547ECHELON Oval V 5.1 MRI System2Cleared 510(K)
- K153447MAGNETOM Spectra2Cleared 510(K)
- K160621SIGNAPioneer2Cleared 510(K)
- K153324Ingenia 1.5T and Ingenia 1.5T S R5.22Cleared 510(K)
- K160185Wrist 32Cleared 510(K)
- K153039MRI Dynamic Analysis Plus2Cleared 510(K)
- K152283MAGNETOM Amira2Cleared 510(K)
- K151074Magnetic Reasonance Imaging System2Cleared 510(K)
- K153003SIGNA Pioneer2Cleared 510(K)
- K152371Vantage Titan 3T2Cleared 510(K)
- K151466MrOpen2Cleared 510(K)
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit2Cleared 510(K)
- K151668S-scan2Cleared 510(K)
- K151015ECHELON Oval V 5.0 MRI System2Cleared 510(K)
- K143345SIGNA Pioneer2Cleared 510(K)
- K143020LiverMultiScan2Cleared 510(K)
- K143606MultiBand SENSE2Cleared 510(K)
- K150427Vantage Titan 1.5T, V3.1, MRT-15102Cleared 510(K)
- K143253O-MAR2Cleared 510(K)
- K143008Vantage Titan 3T2Cleared 510(K)
- K142421G-scan Brio2Cleared 510(K)
- K143128mDIXON XD2Cleared 510(K)
- K142734TRILLIUM Oval MR System2Cleared 510(K)
- K143251SIGNA Creator, SIGNA Explorer2Cleared 510(K)
- K141945ECHOSTAR COMFORT 1.5T MRI2Cleared 510(K)
- K142997RTHawk, HeartVista Workstation with RTHawk2Cleared 510(K)
- K142361Discovery MR750 3.0T2Cleared 510(K)
- K141977MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL2Cleared 510(K)
- K131737SUPERNOVA C5 MRI SYSTEM2Cleared 510(K)
- K142515MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra2Cleared 510(K)
- K142085DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T2Cleared 510(K)
- K141472VANTAGE ELAN2Cleared 510(K)
- K140956LCD MONITOR2Cleared 510(K)
- K133670HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE2Cleared 510(K)
- K133848RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK2Cleared 510(K)
- K140666MR ELASTOGRAPHY2Cleared 510(K)
- K132381CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT2Cleared 510(K)
- K140253MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE2Cleared 510(K)
- K131896SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K133526MDIXON-QUANT2Cleared 510(K)
- K133692IMRI 1.5T AND IMRI 3T S2Cleared 510(K)
- K130692M2 WRIST 2 MRI SYSTEM2Cleared 510(K)
- K133490G-SCAN BRIO2Cleared 510(K)
- K131996S-SCAN2Cleared 510(K)
- K122035HEPAFAT SCAN2Cleared 510(K)
- K133435MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A2Cleared 510(K)
- K132119MAGNETOM PRISMA, MAGNETOM PRISMA FIT2Cleared 510(K)
- K132951MAGNETOM AERA2Cleared 510(K)
- K132376DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T2Cleared 510(K)
- K132831QUIET/SILENT SCANNING SUITE2Cleared 510(K)
- K132160VANTAGE TITAN 3T2Cleared 510(K)
- K131241SWIP2Cleared 510(K)
- K130658ELIXBO PM5452Cleared 510(K)
- K130115DISCOVERY MR750W 3.0T2Cleared 510(K)
- K130885MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT2Cleared 510(K)
- K123510MAGNETOM SKYRA2Cleared 510(K)
- K123522OPTIMA MR450W2Cleared 510(K)
- K130262MAGNETOM ESSENZA WITH SYNGO MR D142Cleared 510(K)
- K123938SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN2Cleared 510(K)
- K120701M2 WRIST MRI SYSTEM2Cleared 510(K)
- K123417BRIVO MR355, OPTIMA MR3602Cleared 510(K)
- K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US2Cleared 510(K)
- K113394MAVRIC SL2Cleared 510(K)
- K122034MRJ 33002Cleared 510(K)
- K123068OPTIMA MR 430S2Cleared 510(K)
- K121434SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO2Cleared 510(K)
- K122026PRISM ACQUIRE PRISM PROCESS PRISM VIEW2Cleared 510(K)
- K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT2Cleared 510(K)
- K121997IMRIS ONCOLOGY PACKAGE2Cleared 510(K)
- K122006G-SCAN BRIO2Cleared 510(K)
- K121160MAGNETOM SPECTRA2Cleared 510(K)
- K121650S-SCAN2Cleared 510(K)
- K121545BELLYBOARD, SBRT ACCESSORIES2Cleared 510(K)
- K120638VANTAGE TITAN2Cleared 510(K)
- K121239MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE2Cleared 510(K)
- K120487VANTAGE TITAN 3T2Cleared 510(K)
- K113281MRI SYTEMS2Cleared 510(K)
- K113511ECHOSTAR SPICA 1.5T MR SYSTEM2Cleared 510(K)
- K120748SPEEDUP SOFTWARE OPTION2Cleared 510(K)
- K113145ECHELON OVAL MRI SYSTEM2Cleared 510(K)
- K120778BRIVO MR3552Cleared 510(K)
- K113490OPTIMA MR450W2Cleared 510(K)
- K113093VANTAGE TITAN 3T2Cleared 510(K)
- K113337VISIA DYNAMIC REVIEW2Cleared 510(K)
- K112003VANTAGE TITAN HSR2Cleared 510(K)
- K111242MAGNETOM AERA AND MAGNETOM SKYRA2Cleared 510(K)
- K103327DISCOVERY MR750W 3.0T2Cleared 510(K)
- K102489VANTAGE TITAN 3T2Cleared 510(K)
- K110942PICA WHOLE-BODY MRI SYSTEM2Cleared 510(K)
- K111803G-SCAN2Cleared 510(K)
- K111226ENDOSCOUT TRACKING SYSTEM2Cleared 510(K)
- K111340HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM2Cleared 510(K)
- K110802A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 182Cleared 510(K)
- K110151ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T2Cleared 510(K)
- K103411IDEAL IQ SOFTWARE OPTION2Cleared 510(K)
- K110238G-SCAN2Cleared 510(K)
- K103330BRIVO MR355, OPTIMA MR3602Cleared 510(K)
- K1032381.5T OPTIMA MR430S2Cleared 510(K)
- K103507MEDICAL VISORS MV1002Cleared 510(K)
- K102344MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS2Cleared 510(K)
- K101813IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO2Cleared 510(K)
- K101347MAGNETOM AERA; MAGNETOM SKYRA2Cleared 510(K)
- K102155MR RADIATION ONCOLOGY OPTIONS2Cleared 510(K)
- K101295MROPEN2Cleared 510(K)
- K093738MRI PATIENT POSITIONING DEVICES2Cleared 510(K)
- K100164MR INSPIRE WITH EXTENDED KIT2Cleared 510(K)
- K093984PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-012Cleared 510(K)
- K092308POLESTAR, MODEL N-302Cleared 510(K)
- K100352DIAGNOSOFT HARP MODEL 2.062Cleared 510(K)
- K093336INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM2Cleared 510(K)
- K0929253D ASL2Cleared 510(K)
- K092469O-SCAN MR SYSTEM2Cleared 510(K)
- K092230MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-012Cleared 510(K)
- K092899OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.42Cleared 510(K)
- K092253MODIFICATION TO FMRI HARDWARE SYSTEM2Cleared 510(K)
- K092237NSM-S15 SYSTEM2Cleared 510(K)
- K091166IMRX2Cleared 510(K)
- K091580PICA WHOLE BODY MRI SYSTEM2Cleared 510(K)
- K083421MR-TOUCH OPTION2Cleared 510(K)
- K091444PERFSCAPE2Cleared 510(K)
- K091536OPTIMA MR450W2Cleared 510(K)
- K091669OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III2Cleared 510(K)
- K090038SYNGO BREVIS2Cleared 510(K)
- K090873I OPEN 0.5T2Cleared 510(K)
- K090433I_OPEN 0.4T2Cleared 510(K)
- K090080CIRRUS OPEN2Cleared 510(K)
- K082964PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)2Cleared 510(K)
- K083533ECHELON C MRI SYSTEM2Cleared 510(K)
- K083137NEURO III-SV2Cleared 510(K)
- K082427SYNGO MR B172Cleared 510(K)
- K083147DISCOVERY MR4502Cleared 510(K)
- K082331MAGNETOM C!2Cleared 510(K)
- K073425MODIFICATION TO AURORA MRI SYSTEM2Cleared 510(K)
- K082485MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A2Cleared 510(K)
- K082100ALLTECH ECHOSTAR 1.5 T MR SYSTEM2Cleared 510(K)
- K081916GE SIGNA MR ONCOLOGY PACKAGE2Cleared 510(K)
- K073362MROPEN2Cleared 510(K)
- K080515FMRI HARDWARE SYSTEM2Cleared 510(K)
- K080762IB NEURO, VERSION 1.02Cleared 510(K)
- K080968S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA2Cleared 510(K)
- K081028SIGNA 3.0T MR750 SYSTEM2Cleared 510(K)
- K080098MRJ EXTENDED2Cleared 510(K)
- K073156QPLAQUE MR2Cleared 510(K)
- K080048MSK EXTREME MR SCANNER, MODEL AA50002Cleared 510(K)
- K073457MSTAR MPD45002Cleared 510(K)
- K080038VANTAGE TITAN, MODEL MRT-1504/S32Cleared 510(K)
- K073167BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER2Cleared 510(K)
- K072473CHASE MR SYSTEM2Cleared 510(K)
- K073081JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X2Cleared 510(K)
- K072850MRI SYSTEM, MODEL MAGFINDER II / AI 32002Cleared 510(K)
- K073099FMRI HARDWARE SYSTEM2Cleared 510(K)
- K070968CHOY COMPRESSION FRAME2Cleared 510(K)
- K072998IDEAL SOFTWARE OPTION FOR GE MR SCANNERS2Cleared 510(K)
- K072237MAGNETOM VERIO2Cleared 510(K)
- K072279MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K071925MAGNETOM ESSENZA2Cleared 510(K)
- K071099NEURO II-SE, MODELS: OR-DR-OR, OR-MB2Cleared 510(K)
- K071154SUPERSTAR 0.35T MRI SYSTEM2Cleared 510(K)
- K063559ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.52Cleared 510(K)
- K063361EXCELART VANTAGE ATLAS, MODEL MRT-15032Cleared 510(K)
- K063207S-SCAN MRI SYSTEM2Cleared 510(K)
- K062454MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES2Cleared 510(K)
- K062860MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A2Cleared 510(K)
- K061916NEURO II-SE, MODELS OR-MB-DR AND OR-DR2Cleared 510(K)
- K061930INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY2Cleared 510(K)
- K061368DIAGNOSOFT HARP2Cleared 510(K)
- K061429DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA2Cleared 510(K)
- K061255BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.02Cleared 510(K)
- K061132MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P0352Cleared 510(K)
- K060956G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/98000100042Cleared 510(K)
- K053309ALTAIRE INTERVENTIONAL MR PACKAGE2Cleared 510(K)
- K060003EXCELART VANTAGE ZGV2Cleared 510(K)
- K052423MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION2Cleared 510(K)
- K052023CADIMAS VERSION 1.02Cleared 510(K)
- K053009GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM2Cleared 510(K)
- K052978GE 1.5T SIGNA HDE MR SYSTEM2Cleared 510(K)
- K052987BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC2Cleared 510(K)
- K052698MODIFICATION TO: AURORA2Cleared 510(K)
- K052571MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.02Cleared 510(K)
- K052164MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A2Cleared 510(K)
- K052579PORTAL GRAVITY SYSTEM2Cleared 510(K)
- K052172HHF1 MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K052315SIMTEC IM-MAXX 2 OPTION2Cleared 510(K)
- K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM2Cleared 510(K)
- K052305MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A2Cleared 510(K)
- K052078ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES2Cleared 510(K)
- K052013ACHIEVA 1.5T & INERA 1.5T FAMILY2Cleared 510(K)
- K050602ALTAIRE2Cleared 510(K)
- K050237STARSHIELD V3 RF TRNT2Cleared 510(K)
- K050200MAGNETOM TRIO A TIM SYSTEM2Cleared 510(K)
- K050199MAGNETOM SYMPHONY A TIM SYSTEM2Cleared 510(K)
- K050132NEURO II-S2Cleared 510(K)
- K043147ACHIEVA FAMILY2Cleared 510(K)
- K043290MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.02Cleared 510(K)
- K043271R2-MRI ANALYSIS SYSTEM2Cleared 510(K)
- K043262GE SIGNA EXCITE MR SURGICAL OPTION2Cleared 510(K)
- K043030MAGNETOM C! MR SYSTEM2Cleared 510(K)
- K043112GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM2Cleared 510(K)
- K042948I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K042236G-SCAN2Cleared 510(K)
- K041602PANORAMA 1.0T2Cleared 510(K)
- K041695LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE2Cleared 510(K)
- K041286DYNACAD V1.02Cleared 510(K)
- K041112MAGNETOM ESPREE SYSTEM2Cleared 510(K)
- K041111MAGNETOM C! MR SYSTEM2Cleared 510(K)
- K041020CADSTREAM VERSION 3.12Cleared 510(K)
- K041577PINNACLE3 RADIATION THERAPY PLANNING SYSTEM2Cleared 510(K)
- K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM2Cleared 510(K)
- K040877ARTOSCAN C2Cleared 510(K)
- K033485ENDOSCOUT2Cleared 510(K)
- K040444GE SIGNA 3.0T WITH EXCITE MR SYSTEM2Cleared 510(K)
- K033507MRJ2Cleared 510(K)
- K033867GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS2Cleared 510(K)
- K033504GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM2Cleared 510(K)
- K033315SUPEROPEN 0.23T, MODEL NAM-P023A2Cleared 510(K)
- K032428MAGNETOM AVANTO MR SYSTEM2Cleared 510(K)
- K033168GE 0.2T SIGNA PROFILE/I MR SYSTEM2Cleared 510(K)
- K032795GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM2Cleared 510(K)
- K032232AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE2Cleared 510(K)
- K032678MODIFICATION TO: AURORA2Cleared 510(K)
- K032541POLESTAR N-202Cleared 510(K)
- K031815INTERA-SENSATION FAMILY2Cleared 510(K)
- K032490TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P22Cleared 510(K)
- K032121MODIFICATION TO E-SCAN XQ2Cleared 510(K)
- K032082AURORA2Cleared 510(K)
- K031731MR FIBER OPTIC ECG GATING SYSTEM2Cleared 510(K)
- K031927GE DELTA SOFTWARE OPTION FOR MRI2Cleared 510(K)
- K030981ECLIPSE2Cleared 510(K)
- K0313503TP SOFTWARE OPTION2Cleared 510(K)
- K031396ADVANTAGE WORKSTATION PASTING 1.12Cleared 510(K)
- K031230GE PROPELLER IMAGING OPTION FOR MRI2Cleared 510(K)
- K030918SUPEROPEN 0.35T, MODEL NSM-P0352Cleared 510(K)
- K030874GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM2Cleared 510(K)
- K030520INTERA FAMILY2Cleared 510(K)
- K024066INFINION SOFTWARE FEATURES2Cleared 510(K)
- K024042PANORAMA ENHANCEMENTS2Cleared 510(K)
- K023686AURORA MR-GUIDED INTERVENTIONAL SYSTEM2Cleared 510(K)
- K023511EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P22Cleared 510(K)
- K023130ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM2Cleared 510(K)
- K022390HITACHI ALTAIRE2Cleared 510(K)
- K023207OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)2Cleared 510(K)
- K022157RF TENT2Cleared 510(K)
- K022397SIGNA 3.0T MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K020991SYNGO MR 2002B2Cleared 510(K)
- K020268ISAAC 1.5 T MR SYSTEM2Cleared 510(K)
- K020289MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS2Cleared 510(K)
- K020573MODIFICATION TO MAGNETOM RHAPSODY SYSTEM2Cleared 510(K)
- K020164E-SCAN XQ2Cleared 510(K)
- K014011CANVAS N-VAS-D 2.02Cleared 510(K)
- K013636SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY2Cleared 510(K)
- K013858INFINION 0.6T MR IMAGING SYSTEM2Cleared 510(K)
- K013586MAGNETOM TRIO SYSTEM2Cleared 510(K)
- K010850POLESTAR N-102Cleared 510(K)
- K013344INTERA I/T2Cleared 510(K)
- K012875SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K012495OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS2Cleared 510(K)
- K013150MR-GUIDE 20002Cleared 510(K)
- K012202NUMARIS 4VA15A2Cleared 510(K)
- K012970GE SIGNA ASSET IMAGING OPTION2Cleared 510(K)
- K012154AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K011416MUSCLE IMAGING SYSTEM (MIS)2Cleared 510(K)
- K0122001.5T INFINITY TWINSPEED MR SYSTEM2Cleared 510(K)
- K011296INFINION ENHANCEMENT PACKAGE2Cleared 510(K)
- K011485PINNACLE MAGNETIC RESONANCE IMAGING SCANNER2Cleared 510(K)
- K011466QED DIODE DETECTORS, MODELS 1112-11162Cleared 510(K)
- K010773BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS2Cleared 510(K)
- K011418ULTRAGUIDE MR-GUIDE 30002Cleared 510(K)
- K010691BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION2Cleared 510(K)
- K002997FIESTA IMAGING OPTION2Cleared 510(K)
- K010570BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 1602Cleared 510(K)
- K003899IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM2Cleared 510(K)
- K003947FUNCTIONAL BRAIN MAPPING OPTION FOR MRI2Cleared 510(K)
- K003651AURORA2Cleared 510(K)
- K003853INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 1002Cleared 510(K)
- K010057MODIFICATION TO ARTOSCAN M2Cleared 510(K)
- K003628MAGNETOM RHAPSODY SYSTEM2Cleared 510(K)
- K003573DIFFUSION TENSOR IMAGING OPTION2Cleared 510(K)
- K003453SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS2Cleared 510(K)
- K003516GYROSCAN INTERA 3.0T2Cleared 510(K)
- K003623INTERACTIVE REAL TIME SCANNING PACKAGE2Cleared 510(K)
- K003192MAGNETIC CONCERTO2Cleared 510(K)
- K002964NEURO II2Cleared 510(K)
- K002611SIGNA MFO/I MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K002531EXCELART WITH PIANISSIMO, MODEL MRT-1501/P32Cleared 510(K)
- K002420HITACHI ALTAIRE2Cleared 510(K)
- K002179MAGNETOM ALLEGRA SYSTEM2Cleared 510(K)
- K002490INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER2Cleared 510(K)
- K002242POLESTAR N-102Cleared 510(K)
- K001987EXPLORER GRADIENT2Cleared 510(K)
- K001796GYROSCAN INTERA (R7.5)2Cleared 510(K)
- K994283MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM2Cleared 510(K)
- K002415POWERDRIVE 350 OPTION2Cleared 510(K)
- K001773ORTHONE2Cleared 510(K)
- K002225OR TABLE/MAGNETOM OPEN VIVA SYSTEM2Cleared 510(K)
- K001894MODIFICATION TO E-SCAN2Cleared 510(K)
- K001334HITACHI AIRIS II2Cleared 510(K)
- K000802SPIRAL IMAGING OPTION2Cleared 510(K)
- K000832STEROTACTIC LOCALIZATION DEVICE (SLD)2Cleared 510(K)
- K000315VENTRICULAR ANALYSIS TOOLKIT OPTION2Cleared 510(K)
- K994351M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM2Cleared 510(K)
- K994287FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER2Cleared 510(K)
- K994282MRI- FLOW ANALYTICAL SOFTWARE PACKAGE2Cleared 510(K)
- K993803EXCELART WITH PIANISSIMO2Cleared 510(K)
- K994117MR ENHANCER2Cleared 510(K)
- K993682MRI EQUIPMENT COVER2Cleared 510(K)
- K993574OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON2Cleared 510(K)
- K994316MAGNETOM OPEN VIVA WITH PERMANENT MAGNET2Cleared 510(K)
- K993731SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM2Cleared 510(K)
- K990329PHILIPS EASYVISION WORKSTATION2Cleared 510(K)
- K992746SIGNA HFO/I MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K990826INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM2Cleared 510(K)
- K992533PHILIPS GYROSCAN INTERA (*)2Cleared 510(K)
- K990153VIRGO MRI SYSTEM2Cleared 510(K)
- K983793PREFERENCE TREATMENT SYSTEM2Cleared 510(K)
- K992892STEPPING KINEMATIC IMAGING PLATFORM (SKIP)2Cleared 510(K)
- K990335PHILIPS EASYVISION WORKSTATION:2Cleared 510(K)
- K992135SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K992225QUANTITATIVE FLOW2Cleared 510(K)
- K991943MRGP OPTICAL TRACKING UNIT2Cleared 510(K)
- K992412IPASS BOLUS TRACKING2Cleared 510(K)
- K992120DYNAWELL OR DYNAWELL2Cleared 510(K)
- K991652HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM2Cleared 510(K)
- K991243NORMA 102Cleared 510(K)
- K990968E-SCAN2Cleared 510(K)
- K990620EXCELART2Cleared 510(K)
- K9905503.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K990260OPART2Cleared 510(K)
- K983110FLEXART,FLEXART/HYPER, VISART, VISART/HYPER2Cleared 510(K)
- K984221FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR2Cleared 510(K)
- K984280AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE2Cleared 510(K)
- K984224PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS2Cleared 510(K)
- K984274MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE2Cleared 510(K)
- K983902FIELD EFFECTS MRI SYSTEM2Cleared 510(K)
- K982959MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC2Cleared 510(K)
- K982932MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC2Cleared 510(K)
- K982834RESTGRID PACKAGE/GYROSCAN NT2Cleared 510(K)
- K982761JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 10312Cleared 510(K)
- K983327ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS2Cleared 510(K)
- K982157TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K980831IMAGE POST-PROCESSING TECHNIQUES2Cleared 510(K)
- K981898ORTHOVU-10002Cleared 510(K)
- K981475OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE2Cleared 510(K)
- K981410HAMMERSMITH ENDOCAVITARY COILS2Cleared 510(K)
- K981190HIGH IMPEDANCE CARDIAC GATING CABLE2Cleared 510(K)
- K981398ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM2Cleared 510(K)
- K980645PHILIPS GYROSCAN NT RELEASE 6 SERIES2Cleared 510(K)
- K973658DIFFUSION PACKAGE / GYROSCAN NT2Cleared 510(K)
- K980417MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V2Cleared 510(K)
- K980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP2Cleared 510(K)
- K980114MAGNETIC RESONANCE DIAGNOSTIC SYSTEM2Cleared 510(K)
- K974844OUTLOOK SYSTEM ENHANCEMENT PACKAGE2Cleared 510(K)
- K974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-01022Cleared 510(K)
- K974498STRATIS II2Cleared 510(K)
- K974212AIRIS II2Cleared 510(K)
- K974530DUFFUSION-WEIGHTED MR IMAGING PACKAGE2Cleared 510(K)
- K972990MAGNETIC RESONANCE DIAGNOSTIC SYSTEM2Cleared 510(K)
- K973799CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT2Cleared 510(K)
- K972826ESTEEM 1.5T MRI SYSTEM2Cleared 510(K)
- K972704KINEMATIC POSITIONERS2Cleared 510(K)
- K970990GYREX PRIMA 1TG 1.0T MRI SYSTEM2Cleared 510(K)
- K971884ASSET APOLLO2Cleared 510(K)
- K971684MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)2Cleared 510(K)
- K971668SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS2Cleared 510(K)
- K970573FLEXART V3.5 SOFTWARE2Cleared 510(K)
- K965068MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE2Cleared 510(K)
- K971380MEDRAD FLEX INTERFACE DEVICE2Cleared 510(K)
- K971279VERSION 4 OPERATING SYSTEM SOFTWARE2Cleared 510(K)
- K971055DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION2Cleared 510(K)
- K965044GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-01022Cleared 510(K)
- K970852MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)2Cleared 510(K)
- K963990GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES2Cleared 510(K)
- K963262ARTOSCAN M2Cleared 510(K)
- K970037TARGOGRID2Cleared 510(K)
- K964778HI-STAR MRI IMAGING SYSTEM2Cleared 510(K)
- K964752KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER2Cleared 510(K)
- K964753MATRIX 3000 FLEXIBLE SPINE COIL2Cleared 510(K)
- K964626EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE2Cleared 510(K)
- K964608MRT-35A V9.02Cleared 510(K)
- K964531PROFILE 70000 QUADRATURE VOLUME NECK COIL2Cleared 510(K)
- K964306MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K964370MAGNETIC RESONANCE DIAGNOSTIC SYSTEM2Cleared 510(K)
- K962249PIXELL MRI SYSTEM2Cleared 510(K)
- K962138FLEXART V3.1 SOFTWARE2Cleared 510(K)
- K963953IMIG-MRI2Cleared 510(K)
- K963429MAGNETIC RESONANCE DIAGNOSTIC SYSTEM2Cleared 510(K)
- K962061MAGNETIC RESONANCE DIAGNOSTIC SYSTEM2Cleared 510(K)
- K963186ORTHO 80002Cleared 510(K)
- K963179MAGNETIC RESONANCE DIAGNOSTIC SYSTEM2Cleared 510(K)
- K962892HELAX TMS BRACHYTHERAPY, VERSION 3.02Cleared 510(K)
- K962933OPART MRT-6002Cleared 510(K)
- K963345ADVANTAGE WINDOWS TISSUE VOLUME OPTION2Cleared 510(K)
- K961624FLEXART TMJ COIL2Cleared 510(K)
- K962927IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS2Cleared 510(K)
- K962677ESTEEM 1.5T MRI SYSTEM2Cleared 510(K)
- K961969HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE2Cleared 510(K)
- K962618GYREX V-EP2Cleared 510(K)
- K962117QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS2Cleared 510(K)
- K9620481W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)2Cleared 510(K)
- K961842SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K961876AIRIS2Cleared 510(K)
- K960497FLEXIBLE PHASED ARRAY SPINE COIL2Cleared 510(K)
- K961366MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS2Cleared 510(K)
- K961238MRT-50A/150A SOFTWARE UPGRADE V12.0/12.12Cleared 510(K)
- K961174ECG MONITOR MODEL DS-3130/31402Cleared 510(K)
- K961121KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM2Cleared 510(K)
- K961092VISART2Cleared 510(K)
- K955389MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM2Cleared 510(K)
- K960973MOVABLE ADD-ON COUCH FOR OUTLOOK2Cleared 510(K)
- K960901MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL2Cleared 510(K)
- K960294PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK2Cleared 510(K)
- K954353MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K954354MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K955811AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM2Cleared 510(K)
- K960181VERSION 3.7 OPERATING SYSTEM SOFTWARE2Cleared 510(K)
- K950837AURORA IMAGING SYSTEM2Cleared 510(K)
- K954646EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS2Cleared 510(K)
- K945945GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT2Cleared 510(K)
- K954039GYREX PRIVILEGE2Cleared 510(K)
- K942604SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K954355ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION2Cleared 510(K)
- K951650CLINICAL PROTON SPECTROSCOPY OPTION2Cleared 510(K)
- K951681QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER2Cleared 510(K)
- K953248IRIS BILATERAL TMJ2Cleared 510(K)
- K953262QD BILATERAL BREAST COIL2Cleared 510(K)
- K945517MAGNETOM VISION (PROJECT 016)2Cleared 510(K)
- K943440PROFILE 7000 C-SPINE COIL2Cleared 510(K)
- K945791GYRES 2T PRESTIGE2Cleared 510(K)
- K945827OUTLOOK2Cleared 510(K)
- K953918MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K944724HEALTH IMAGE INC. HI STAR2Cleared 510(K)
- K945779MAGNETOM VISION (PROJECT 016)2Cleared 510(K)
- K945730SIGNA PROFILE2Cleared 510(K)
- K943189MEDRAD QWIK-FIX MRI DISPOSABLE KIT2Cleared 510(K)
- K952530HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE2Cleared 510(K)
- K944228HEALTH IMAGES, INC. HI-STANDARD2Cleared 510(K)
- K952232MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-152Cleared 510(K)
- K952235MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-152Cleared 510(K)
- K951649MODEL #801GE1500 PEDIATRIC ARRAY COIL2Cleared 510(K)
- K944070ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING2Cleared 510(K)
- K941666SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS2Cleared 510(K)
- K944979MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K946085THIN-FILM CARDIAC GATING CABLE2Cleared 510(K)
- K945155AIRIS2Cleared 510(K)
- K943798MRH-15002Cleared 510(K)
- K950973MAGNETIC RESONANCE DIAGNOSTIC SYSTEM2Cleared 510(K)
- K945875MRT-50 QD BODY COIL2Cleared 510(K)
- K945828ECHO PLANAR IMAGING I2Cleared 510(K)
- K940772ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)2Cleared 510(K)
- K945798MRT-35A UPGRADE 8.0CD2Cleared 510(K)
- K945665FLEXART(TM) QD C-SPINE COIL2Cleared 510(K)
- K945778PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL2Cleared 510(K)
- K945386STRATIS2Cleared 510(K)
- K945397ANGIO II2Cleared 510(K)
- K946244ACCESS(TM) COMPASS BED2Cleared 510(K)
- K942669SMT-50CX/H2Cleared 510(K)
- K941864MRT-150A, MRT-150A SOFTWARE VERSION 11.92Cleared 510(K)
- K941622ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION2Cleared 510(K)
- K944773MODEL 405GE-64: PHASED ARRAY TMJ COIL2Cleared 510(K)
- K944662FLEXART QD BODY COIL2Cleared 510(K)
- K944469GENERAL PURPOSE FLEX COIL2Cleared 510(K)
- K944331MODEL 528GE SERIES2Cleared 510(K)
- K9438002D,3D, TOF MR ANGIOGRAPHY2Cleared 510(K)
- K941582SUPERSENSOR MRI COIL2Cleared 510(K)
- K944112MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K943415MERIT (O.1T MR SYSTEM)2Cleared 510(K)
- K943799VERSION 5 OPERATING SYSTEM SOFTWARE2Cleared 510(K)
- K942874MODEL #300TO3500 SHOULDER COIL2Cleared 510(K)
- K942873MODEL #700TO3500 NECK/ABDOMINAL COIL2Cleared 510(K)
- K942875MODEL #900TO3500 HEAD/NECK COIL2Cleared 510(K)
- K943320HEAD AND NECK COIL FOR THE GYREX 2T-DLX2Cleared 510(K)
- K940534GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)2Cleared 510(K)
- K940541MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)2Cleared 510(K)
- K943021MRT-150A2Cleared 510(K)
- K942953ORACLE MRI WHOLE BODY MR IMAGING SYSTEM2Cleared 510(K)
- K943321QUAD PELVIS COIL2Cleared 510(K)
- K942776MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S12Cleared 510(K)
- K942355MODEL #310T03500 WRIST COIL2Cleared 510(K)
- K934987CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX2Cleared 510(K)
- K942560MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K942609MRT-150A SHOULDER COIL2Cleared 510(K)
- K940894MAGNA SL2Cleared 510(K)
- K941996EDGE2Cleared 510(K)
- K935549GYREX 2T-SGR2Cleared 510(K)
- K940796ACCESS2Cleared 510(K)
- K934318DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL2Cleared 510(K)
- K941812SLICES2Cleared 510(K)
- K935691MODEL GP-252 GENERAL PURPOSE COIL2Cleared 510(K)
- K941408MERIT2Cleared 510(K)
- K935224VOLUME NECK COIL FOR THE GYREX V-DIX2Cleared 510(K)
- K930193PHILIPS ENDO-CAVITARY MRI COIL2Cleared 510(K)
- K940364MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K934514CATCH AND HOLD OPTION FOR INSTASCAN2Cleared 510(K)
- K941025PHASED ARRAY BREAST COIL2Cleared 510(K)
- K940874MODEL 900GE1500 HEAD/NECK COIL2Cleared 510(K)
- K940602EXTRA LARGE QUAD FLEX SPINE COIL2Cleared 510(K)
- K935015QUADRATURE SMALL EXTREMITY COIL2Cleared 510(K)
- K94051441OTO-15: SHOULDER COIL SET 411TO-15 412TO-152Cleared 510(K)
- K934538MRI RESONANCE DIAGNOSTIC DEVICE ACCESORY2Cleared 510(K)
- K935670VERSION 3 OPERATING SYSTEM SOFTWARE2Cleared 510(K)
- K9356712D, 3D TOF MR ANGIOGRAPHY2Cleared 510(K)
- K935752CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS2Cleared 510(K)
- K935627CP BODY ARRAY/ CP SPINE ARRAY COIL2Cleared 510(K)
- K935450PHASED ARRAY PELVIC COIL2Cleared 510(K)
- K935369FAST SPIN ECHO (FSE)2Cleared 510(K)
- K933295MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA2Cleared 510(K)
- K933296MODEL #310GE1500 WRIST COIL2Cleared 510(K)
- K935661MAGNETOM OPEN2Cleared 510(K)
- K935664FAST SPIN ECHO2Cleared 510(K)
- K935570NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K931460VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K932403AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN2Cleared 510(K)
- K933018MRT-50GP2Cleared 510(K)
- K932244SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K935084INCREASED SAR PACKAGE FOR MRT-150A2Cleared 510(K)
- K932552SPORTS MEDICINE QUADRATURE SHOULDER COIL2Cleared 510(K)
- K934485HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION2Cleared 510(K)
- K930708PHILIPS GYROSCAN T5 II RELEASE 32Cleared 510(K)
- K931298SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K932271MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 0162Cleared 510(K)
- K934719EXTRA LARGE QUAD FLEX SPINE COIL2Cleared 510(K)
- K934212FAST SPIN ECHO2Cleared 510(K)
- K934499MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K933356MERIT2Cleared 510(K)
- K932091PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL2Cleared 510(K)
- K931656MERIT2Cleared 510(K)
- K931454IMAGEACCESS SYSTEM2Cleared 510(K)
- K932644PHILIPS GYROSCAN TN5 & TN5 LITE2Cleared 510(K)
- K932645PHILIPS GYROSCAN TN 152Cleared 510(K)
- K925858OE 1.5 SI2Cleared 510(K)
- K934396QUADRATURE LOWER EXTREMITY COIL2Cleared 510(K)
- K9338350.5T ASSET SYSTEM2Cleared 510(K)
- K933659MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL2Cleared 510(K)
- K9315441.5T EDGE AND 1.0T VISTA SYSTEMS2Cleared 510(K)
- K933658MODEL 300GE1500 SHOULDER COIL2Cleared 510(K)
- K933645ECG GATING HARDWARE FOR MRP-5000 AND MRP-70002Cleared 510(K)
- K930709PHILIPS GYROSCAN ACS-II RELEASE 32Cleared 510(K)
- K933297MODEL #510GE1500 LIVER ARRAY COIL2Cleared 510(K)
- K931392ECG GATING UNIT2Cleared 510(K)
- K930960ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY2Cleared 510(K)
- K926275PHILIPS MRI BREAST COIL2Cleared 510(K)
- K932344MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES2Cleared 510(K)
- K926001MRT-50A, MRT-150A2Cleared 510(K)
- K932693EDGE SYSTEM2Cleared 510(K)
- K931022ARTOSCAN2Cleared 510(K)
- K930779MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-152Cleared 510(K)
- K925985GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.02Cleared 510(K)
- K925597SNR-3000 UPGRADE RECEIVER COILS2Cleared 510(K)
- K925286MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE2Cleared 510(K)
- K930544MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-152Cleared 510(K)
- K930674MODEL 640GE-64: QUADRATURE PELVIC COIL2Cleared 510(K)
- K932375MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI2Cleared 510(K)
- K932374MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL2Cleared 510(K)
- K930811MODIFIED BODY HELMHOLTZ COIL2Cleared 510(K)
- K932338MAGNETOM P82Cleared 510(K)
- K932292AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS2Cleared 510(K)
- K930122MODEL 600GE-64: BILATERAL BREAST COIL2Cleared 510(K)
- K930045MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL2Cleared 510(K)
- K926571MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-152Cleared 510(K)
- K931008MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL2Cleared 510(K)
- K930991BILATERAL TEMPORAL MANDIBULAR JOINT COIL2Cleared 510(K)
- K922846MRH-15002Cleared 510(K)
- K924605MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K926416SAT PAD(TM)2Cleared 510(K)
- K925987INSTRUMENTARIUM MEGA4 HT2Cleared 510(K)
- K925029MRINNERVU ENDORECTAL PROSTATE COIL2Cleared 510(K)
- K924921INSTRUMENTARIUM MEGA4 HT2Cleared 510(K)
- K921891SILENT SCAN2Cleared 510(K)
- K924472INSTRUMENTARIUM MEGA4 HT2Cleared 510(K)
- K923581INSTRUMENTARIUM MEGA4 HT2Cleared 510(K)
- K926171MRT-150A, QD SPINE COIL2Cleared 510(K)
- K924808MRT-50A SUPER2Cleared 510(K)
- K923944PHILIPS GYROVIEW HR - RELEASE 22Cleared 510(K)
- K926397FAST SPIN ECHO MEASURING FUNCTION2Cleared 510(K)
- K923984SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K9250092D TOF ANGIOGRAHY MEASURING FUNCTION2Cleared 510(K)
- K925845VISTA HP/HPQ SYSTEM2Cleared 510(K)
- K925107SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K924489SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST2Cleared 510(K)
- K9238703DTOF MRA2Cleared 510(K)
- K924756MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL2Cleared 510(K)
- K924653MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL2Cleared 510(K)
- K924479MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES2Cleared 510(K)
- K923423QUADATURE HEAD/NECK/VASCULAR COIL2Cleared 510(K)
- K923140MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL2Cleared 510(K)
- K921653VECTRA MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K924426MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG2Cleared 510(K)
- K924349GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP2Cleared 510(K)
- K923025SIGNA BREAST COIL AND ARRAY ACCESSORY2Cleared 510(K)
- K922470IES, IMAGE ENHANCEMENT SYSTEM2Cleared 510(K)
- K924154KINEMATIC MRI MOVIEMAKER2Cleared 510(K)
- K921940MRT-35(TM)2Cleared 510(K)
- K921941SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT2Cleared 510(K)
- K923948SAT PAD2Cleared 510(K)
- K920791GYROSCAN S15/ACS-II2Cleared 510(K)
- K920578PHILIPS GYROSCAN T5 SERIES II2Cleared 510(K)
- K923881QUADRATURE CERVICAL CONTOUR COIL2Cleared 510(K)
- K9238233D IMAGING2Cleared 510(K)
- K923897A BREAST COIL FOR THE GYREX 2T-DIX2Cleared 510(K)
- K923615VISTA HPQ SYSTEM2Cleared 510(K)
- K923352INSTRUMENTARIUM MEGA4 HT2Cleared 510(K)
- K923264GENERAL PURPOSE FLEX COIL2Cleared 510(K)
- K923022INSTRUMENTARIUM MEGA4 HT2Cleared 510(K)
- K922798QD WHOLE BODY COIL, MRT-150A2Cleared 510(K)
- K922677MAGNETIZATION TRANSFER CONTRAST2Cleared 510(K)
- K923010MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K920227QUADRATURE SHOULDER CONTOUR COIL2Cleared 510(K)
- K920714VISTA HPQ SYSTEM2Cleared 510(K)
- K921413MRT-502Cleared 510(K)
- K920204INSTASCAN2Cleared 510(K)
- K9204413D TOF ANGIOGRAPHY MEASURING FUNCTION2Cleared 510(K)
- K922006QQUADRATURE LUMBAR CONTOUR COIL2Cleared 510(K)
- K922000MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL2Cleared 510(K)
- K921881VISTA HPQ SYSTEM2Cleared 510(K)
- K921720MRT-50A QD SPINE COIL2Cleared 510(K)
- K920543MRI OE 1.5 SI2Cleared 510(K)
- K920096MRT-150 QD KNEE COIL2Cleared 510(K)
- K920789B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER2Cleared 510(K)
- K920254COILS FOR RX4000 & RX5000 MRI SYSTEMS2Cleared 510(K)
- K921609VISTA HP/HPQ SYSTEM2Cleared 510(K)
- K920098ACCESS QD HEAD COIL2Cleared 510(K)
- K921046BO POWER SUPPLY2Cleared 510(K)
- K920835PRESATURATION2Cleared 510(K)
- K921098MAGNETOM 63SP2Cleared 510(K)
- K920094MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES2Cleared 510(K)
- K915567MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY)2Cleared 510(K)
- K920095MRT-50 MULTIVIEW COIL2Cleared 510(K)
- K920215INSTRUMENTARIUM MEGA4 HT2Cleared 510(K)
- K920126MRT-50 FLEXIBLE BODY COIL2Cleared 510(K)
- K920125MRT-50 SPINE COIL2Cleared 510(K)
- K920097MRT-50 QD HEAD COIL2Cleared 510(K)
- K91575416 BIT A/D2Cleared 510(K)
- K915873MOS-III2Cleared 510(K)
- K915260MRI ULTRAVIEW2Cleared 510(K)
- K915657MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R282Cleared 510(K)
- K920199HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST2Cleared 510(K)
- K920159MOBILE MRP-70002Cleared 510(K)
- K914209MODEL 310GE-64: WHOLE VOLUME NECK COIL2Cleared 510(K)
- K915552INSTRUMENTARIUM MEGA42Cleared 510(K)
- K9155793D PROCESSING OPTIONS FOR GYREX2Cleared 510(K)
- K915601GYREX 2T-DLX2Cleared 510(K)
- K915598SPECIAL PURPOSE COILS FOR GYREX V2Cleared 510(K)
- K915395MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY2Cleared 510(K)
- K913673VECTRA MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K915112MAGNETOM 42 SP,63 SP,IMPACT2Cleared 510(K)
- K913770ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION2Cleared 510(K)
- K9141142DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)2Cleared 510(K)
- K913463MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN2Cleared 510(K)
- K914536MODELS 190GE-64/191GE-64/192GE-64/193GE-642Cleared 510(K)
- K914535MODEL 311GE-64: WHOLE VOLUME NECK COIL2Cleared 510(K)
- K914012MRT-150A2Cleared 510(K)
- K913869RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM2Cleared 510(K)
- K914263MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS2Cleared 510(K)
- K911993MRH-5002Cleared 510(K)
- K911872PHILIPS RIGID VOLUME COILS2Cleared 510(K)
- K914019MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)2Cleared 510(K)
- K91332540-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE2Cleared 510(K)
- K913475MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K911975SMT-100X2Cleared 510(K)
- K913441MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT2Cleared 510(K)
- K912963INSTRUMENTARIUM MEGA42Cleared 510(K)
- K912539SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K913534VISTA HPQ SYSTEM2Cleared 510(K)
- K913563MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY2Cleared 510(K)
- K911959SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF2Cleared 510(K)
- K912881GE MR MAX2Cleared 510(K)
- K911746H.I.STANDARD CALIBRE UPGRADE2Cleared 510(K)
- K912410COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM2Cleared 510(K)
- K912095MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K910839ULTIMATE 30002Cleared 510(K)
- K911991MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K905578VIEWNET2Cleared 510(K)
- K911800COIL FIELD EXTENDER2Cleared 510(K)
- K911806MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K911276MAGNETIC RESONANCE DEVICE ACCESSORY2Cleared 510(K)
- K911495MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)2Cleared 510(K)
- K911348RIGID ENDOSCOPE2Cleared 510(K)
- K911892RX-5000 MRI SYSTEM2Cleared 510(K)
- K910715VISTA HPQ SYSTEM2Cleared 510(K)
- K911667HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE2Cleared 510(K)
- K911642MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION2Cleared 510(K)
- K910802POWER SCAN 10002Cleared 510(K)
- K910817GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR2Cleared 510(K)
- K905634SMT-50X2Cleared 510(K)
- K91026910 ADJUSTABLE BELT COIL2Cleared 510(K)
- K910498MAGNETOM 42 SP AND 63 SP2Cleared 510(K)
- K910220MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL2Cleared 510(K)
- K910513MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER2Cleared 510(K)
- K910514MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER2Cleared 510(K)
- K905603PHILIPS GYROVIEW-HR IMAGING WORKSTATION2Cleared 510(K)
- K905512ANTERIOR NECK CONTOUR COIL2Cleared 510(K)
- K905833MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY2Cleared 510(K)
- K905832MRP -5000(1): VERSION 2.0 SOFTWARE2Cleared 510(K)
- K905834MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY2Cleared 510(K)
- K905835MRP-7000: SUPPLEMENTAL R/F COILS2Cleared 510(K)
- K905366MAGNETOM SP/AS (ACTIVELY SHIELDED)2Cleared 510(K)
- K905858CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION2Cleared 510(K)
- K905615MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL2Cleared 510(K)
- K905259VISTA HPQ SYSTEM2Cleared 510(K)
- K905095MODEL 3100-21: QUADRATURE SPINE COIL2Cleared 510(K)
- K905104MODEL 3100-64: QUADRATURE SPINE COIL2Cleared 510(K)
- K905070VISTAR2Cleared 510(K)
- K905442MRT35-SP2Cleared 510(K)
- K905441MRT 35-A (TM)2Cleared 510(K)
- K904528INSTRUMENTARIUM MEGA4, MODIFICATION2Cleared 510(K)
- K904327ADVANCED C- SPINE COIL2Cleared 510(K)
- K903768MAGNETIC RESONANCE DEVICE MRT 150A2Cleared 510(K)
- K903770MRT 50A2Cleared 510(K)
- K903318MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-302Cleared 510(K)
- K903661BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD2Cleared 510(K)
- K903753CAT. #6000-21 VOLUME NECK COIL, MODIFIED2Cleared 510(K)
- K903754CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED2Cleared 510(K)
- K903755CAT/ #4100-21 SHOULDER COIL PACKAGE, MODIFIED2Cleared 510(K)
- K902799GYROSCAN S15/ACS2Cleared 510(K)
- K903822MODEL 4500-SMS-42; SHOULDER COIL2Cleared 510(K)
- K903527MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET2Cleared 510(K)
- K902217TEMPOROMANDIBULAR JOINT (TMJ) COIL2Cleared 510(K)
- K902663GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP2Cleared 510(K)
- K903203MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION2Cleared 510(K)
- K903028GYREX 2T VERSION 2.1U.2Cleared 510(K)
- K903204MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL2Cleared 510(K)
- K903048VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K902933TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)2Cleared 510(K)
- K902044MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K903319MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K901952MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL2Cleared 510(K)
- K901888PROSTATE PROBE SURFACE COIL, CATALOG #BPX-152Cleared 510(K)
- K902314LARGE FLEXIBLE BODY COIL2Cleared 510(K)
- K902310SOFTWARE RELEASE 4.2P, ACCESS(TM)2Cleared 510(K)
- K902315CERVICAL COIL MRT 50A2Cleared 510(K)
- K902316KNEE QD COIL MRT 50A2Cleared 510(K)
- K902630BILATERAL TMJ COIL2Cleared 510(K)
- K901730GE SIGNA ADVANTAGE2Cleared 510(K)
- K901980MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K901864MODEL 4050-21; 5.25 LOOP SHOULDER COIL2Cleared 510(K)
- K901818ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 632Cleared 510(K)
- K901639MODEL 4050-64; 5.25 & 4065-64; 6.50 LOOP COIL2Cleared 510(K)
- K900919MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS2Cleared 510(K)
- K901602VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-40002Cleared 510(K)
- K901620MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI2Cleared 510(K)
- K900026BRUKER R28 WHOLE-BODY MR SCANNER2Cleared 510(K)
- K901384MODEL 6000-21; VOLUME NECK COIL2Cleared 510(K)
- K901305MODEL 2121-21, TMJ SURFACE COIL2Cleared 510(K)
- K901242MODEL 2121-64; TMJ SURFACE COIL2Cleared 510(K)
- K901241THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-642Cleared 510(K)
- K901092MODEL 8010; EXTREMITY SURFACE COIL2Cleared 510(K)
- K900889MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES2Cleared 510(K)
- K900725RADIO FREQUENCY RECEIVER SUBSYSTEM2Cleared 510(K)
- K900283MRT 50A SOFTWARE RELEASE 9.02Cleared 510(K)
- K900728MRT 50A KNEE COIL2Cleared 510(K)
- K900727MRT 50A JOINT COIL2Cleared 510(K)
- K900288MRT 50A BRAIN QD COIL2Cleared 510(K)
- K900285MRT 50A FLEXIBLE BODY COIL2Cleared 510(K)
- K900284MRT 50A 150MM CIRCULAR SURFACE COIL2Cleared 510(K)
- K900289MRT 50A 100MM CIRCULAR SURFACE COIL2Cleared 510(K)
- K900064VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K895328MAGNETIC RESONANCE SYSTEM MODEL BMT-11002Cleared 510(K)
- K900287MRT 50A CRANIO-CERVICAL COIL2Cleared 510(K)
- K900286MRT 50A SPINE SURFACE COIL2Cleared 510(K)
- K896419MODEL: GYREX VERSION V2Cleared 510(K)
- K895629MODEL 8100; UPPER EXTREMITY COIL2Cleared 510(K)
- K896789MODEL 6000; VOLUME NECK COIL2Cleared 510(K)
- K896508VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K896309MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC2Cleared 510(K)
- K894855MODEL 5070; DUAL PLANAR PAIR2Cleared 510(K)
- K896336MODEL SPINE SURVEYOR-PLUS; CAT. #ACS-10A2Cleared 510(K)
- K896647GYROVIEW HR HIGH RESOLUTION WORKSTATION2Cleared 510(K)
- K895869GYROSCAN T5 MOBILE2Cleared 510(K)
- K895966MAGNETOM M, H, 42, 63, 42 SP AND 63 SP2Cleared 510(K)
- K894016MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-202Cleared 510(K)
- K895794GE MR MAX SYSTEM2Cleared 510(K)
- K8947141989 SOFTWARE REVISION TO THE BMT-11002Cleared 510(K)
- K893744SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K895151VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K895131MODEL 2031 TMJ SURFACE COIL2Cleared 510(K)
- K893518MT/S SOFTWARE RELEASE 5.0.2Cleared 510(K)
- K895221ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 422Cleared 510(K)
- K894974MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM2Cleared 510(K)
- K894290ACCESS TM2Cleared 510(K)
- K893509GE SIGNA ADVANTAGE2Cleared 510(K)
- K893750MRT-50A MOBILE2Cleared 510(K)
- K893640SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM2Cleared 510(K)
- K893689VISION INTEGRATED PERFORMANCE OPTION2Cleared 510(K)
- K893739VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES2Cleared 510(K)
- K893675VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES2Cleared 510(K)
- K893881ACCESS TM2Cleared 510(K)
- K893619VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K891760MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED2Cleared 510(K)
- K891543MAGNAVIEW MOBILE MRI VERSION 110 FHM2Cleared 510(K)
- K890092HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K891769MAGNISCAN 5000 MR SYSTEM2Cleared 510(K)
- K892959VERSION 4.2 APPLICATION SOFTWARE2Cleared 510(K)
- K892235GE SHOULDER SURFACE COIL, CAT. #M1085AN2Cleared 510(K)
- K891598MODEL 2030; 3 TMJ SURFACE COIL2Cleared 510(K)
- K891541MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.2Cleared 510(K)
- K890855MODEL 4041; 4 ANGLED PAIR CRC SURFACE COIL2Cleared 510(K)
- K890789GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE2Cleared 510(K)
- K890666MODEL 3031; CERVICAL SPINE SURFACE COIL2Cleared 510(K)
- K890815MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES2Cleared 510(K)
- K890394MEDRAD SCPD 10002Cleared 510(K)
- K885047VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K885223RMI SHORT DISTANCE ALIGNMENT DEVICE2Cleared 510(K)
- K884816ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY2Cleared 510(K)
- K883898MAGNETOM 42 SP AND MAGNETOM 63 SP2Cleared 510(K)
- K884484MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL2Cleared 510(K)
- K884607MT/S (SOFTWARE RELEASE 3.1)2Cleared 510(K)
- K884743TEMPOROMANDIBULAR JOINT COIL (TMJ)2Cleared 510(K)
- K884606MT/S (SPINE TRANSMIT COIL)2Cleared 510(K)
- K884603SHOULDER TRANSMIT AND RECEIVE COILS2Cleared 510(K)
- K884604MT/S CARLSON SPINE COIL, PART # 100-50082500-012Cleared 510(K)
- K883547GE MR MAX SYSTEM2Cleared 510(K)
- K884369POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM2Cleared 510(K)
- K884062MAGNETOM (M, H, 42, 63) SEQUENCES2Cleared 510(K)
- K883994VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K883872CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL2Cleared 510(K)
- K883756TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM2Cleared 510(K)
- K883621INSTRUMENTARIUM ULF MR IMAGING SYSTEM2Cleared 510(K)
- K883699B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER2Cleared 510(K)
- K883648BETA 3000M MOBILE NMR IMAGING SYSTEM2Cleared 510(K)
- K883649INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H2Cleared 510(K)
- K883519FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)2Cleared 510(K)
- K883482VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K883737VFQ HEAD COIL2Cleared 510(K)
- K8835200.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST2Cleared 510(K)
- K883516DIASONICS MT/P IMAGING SYSTEM2Cleared 510(K)
- K883378VISTA MR 2055 HP SYSTEM2Cleared 510(K)
- K883650INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 1102Cleared 510(K)
- K883622INSTRUMENTARIUM ULF MR IMAGING SYSTEM2Cleared 510(K)
- K883521C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS2Cleared 510(K)
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P860062RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P860010INSTRUMENTARIUM ULF MR IMAGING SYSTEM2PMA Approval
- P860062RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST2PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830081MAGNETOM2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P840063GYROSCAN(TM)2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P840063GYROSCAN(TM)2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P840007GYREX2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830081MAGNETOM2PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830081MAGNETOM2PMA Approval
- P850043MAGNISCAN 5000 MRI SYSTEM2PMA Approval
- P850043MAGNISCAN 5000 MRI SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P840007GYREX, MODELS S3500 & S50002PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830081MAGNETOM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P840063GYROSCAN(TM)2PMA Approval
- P840063GYROSCAN(TM)2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P860010INSTRUMENTARIUM ULF MR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P860010ACUTSCAN MODEL 100 MRI SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P840063GYROSCAN(TM)2PMA Approval
- P840007GYREX, MODELS S3500 & S50002PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P840063GYROSCAN(TM)2PMA Approval
- P840063GYROSCAN(TM)2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830081MAGNETOM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830052NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 10002PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830074GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830076FONAR NMR WHOLE BODY SCANNER BETA 30002PMA Approval
- P830081MAGNETOM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830081MAGNETOM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830051TESLACON(TM) NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS NMR IMAGING SYSTEM2PMA Approval
- P830053DIASONICS MT/S (MAGNETIC TOMOGRAPHY/SUPERCONDUCTIN2PMA Approval
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- 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
- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- 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
Swoop® Portable MR Imaging® System (V2)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K250236
- 510(k) Type
- Traditional
- Applicant
- Hyperfine, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/30/2025
- Days to Decision
- 123 days
- Submission Type
- Summary