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
- K244008Spectral CT2Cleared 510(K)
- K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis2Cleared 510(K)
- K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option2Cleared 510(K)
- K243240Vitrea CT VScore2Cleared 510(K)
- K242811BodyTom 642Cleared 510(K)
- K242411Brainomix 360 e-Lung2Cleared 510(K)
- K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime2Cleared 510(K)
- K243229Bunkerhill AVC2Cleared 510(K)
- K241166uCT 5502Cleared 510(K)
- K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option2Cleared 510(K)
- K241079uCT 7802Cleared 510(K)
- K241757syngo.CT Dual Energy2Cleared 510(K)
- K242403Aquilion ONE (TSX-308A/3) V1.52Cleared 510(K)
- K242188ClearRead CT CAC2Cleared 510(K)
- K242874Gating Reflector Block2Cleared 510(K)
- K240844Spectral CT 7500 RT2Cleared 510(K)
- K240369CAC (gated) Algorithm2Cleared 510(K)
- K241295SOMATOM On.site2Cleared 510(K)
- K241440HealthCCSng2Cleared 510(K)
- K233731CardIQ Suite2Cleared 510(K)
- K241713HiRise (1040-230)2Cleared 510(K)
- K233767OmniTom Elite2Cleared 510(K)
- K233875Brainomix 360 e-Lung2Cleared 510(K)
- K232491CT 53002Cleared 510(K)
- K233583FCT iSTREAM Phase 12Cleared 510(K)
- K233698True Enhance DL2Cleared 510(K)
- K232227ABLATE-IQ2Cleared 510(K)
- K233750ECG-less Cardiac2Cleared 510(K)
- K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System2Cleared 510(K)
- K233657NAEOTOM Alpha2Cleared 510(K)
- K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed2Cleared 510(K)
- K233753AI-Rad Companion (Pulmonary)2Cleared 510(K)
- K232022CAS-One IR2Cleared 510(K)
- K233749Revolution Ascend Sliding2Cleared 510(K)
- K233080HealthFLD2Cleared 510(K)
- K234030Clear Guide SCENERGY2Cleared 510(K)
- K232412LungQ v3.0.02Cleared 510(K)
- K232136syngo.CT Applications2Cleared 510(K)
- K233334Aquilion Serve SP (TSX-307B/1) V1.32Cleared 510(K)
- K232206SOMATOM Pro.Pulse2Cleared 510(K)
- K232155syngo.CT Dual Energy2Cleared 510(K)
- K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis2Cleared 510(K)
- K231631BriefCase-Quantification2Cleared 510(K)
- K232392CT Lung Ventilation Analysis Software (CT:V)2Cleared 510(K)
- K232045MeVis Liver Suite2Cleared 510(K)
- K230370SpotLight/SpotLight Duo (with DLIR option)2Cleared 510(K)
- K231574Scenaria View 4.22Cleared 510(K)
- K230220NeuViz 128 Multi-Slice CT Scanner System2Cleared 510(K)
- K230130Micromate™ Navi+2Cleared 510(K)
- K231281Aquilion Serve (TSX-307A/1) V1.32Cleared 510(K)
- K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis2Cleared 510(K)
- K223424Spine Auto Views2Cleared 510(K)
- K223261Open Rib2Cleared 510(K)
- K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash2Cleared 510(K)
- K230112CAC Software2Cleared 510(K)
- K223447OmniTom Elite2Cleared 510(K)
- K223758Epione2Cleared 510(K)
- K230223iCAC Device2Cleared 510(K)
- K230807Deep Learning Image Reconstruction2Cleared 510(K)
- K222360AI-Rad Companion (Cardiovascular)2Cleared 510(K)
- K223514Spectral Bone Marrow2Cleared 510(K)
- K223726Aquilion Precision (TSX-304A/4) V10.14 with AiCE2Cleared 510(K)
- K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i2Cleared 510(K)
- K223028uCT ATLAS Astound with uWS-CT-Dual Energy Analysis2Cleared 510(K)
- K223804PercuNav Image Fusion and Interventional Navigation System2Cleared 510(K)
- K223311Philips CT 35002Cleared 510(K)
- K213465CardioGraphe2Cleared 510(K)
- K222361AI-Rad Companion (Musculoskeletal)2Cleared 510(K)
- K213759XACT Robotic System, ACE Model2Cleared 510(K)
- K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCE2Cleared 510(K)
- K220910Medical image processing software2Cleared 510(K)
- K213713AI-Rad Companion (Pulmonary)2Cleared 510(K)
- K220961Deep Learning Image Reconstruction2Cleared 510(K)
- K221727syngo.CT Extended Functionality2Cleared 510(K)
- K220814NAEOTOM Alpha, Scan&GO Software2Cleared 510(K)
- K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A2Cleared 510(K)
- K213829SCENARIA View2Cleared 510(K)
- K221219syngo.CT CaScoring2Cleared 510(K)
- K221116XACT ACE Robotic System2Cleared 510(K)
- K212875Spectral CT on Rails2Cleared 510(K)
- K220664NewTom 7G2Cleared 510(K)
- K211180Liver Suite2Cleared 510(K)
- K213649BodyTom 642Cleared 510(K)
- K212441Philips Incisive CT2Cleared 510(K)
- K213944HealthOST2Cleared 510(K)
- K212889Syngo.CT Dual Energy2Cleared 510(K)
- K213725CardIQ Suite2Cleared 510(K)
- K220450syngo.CT Applications2Cleared 510(K)
- K211711OmniTom Elite2Cleared 510(K)
- K211645Epione2Cleared 510(K)
- K213999Deep Learning Image Reconstruction2Cleared 510(K)
- K213938Revolution Ascend2Cleared 510(K)
- K214019syngo.CT Extended Functionality2Cleared 510(K)
- K213927Respiratory Gating for Scanners v2.02Cleared 510(K)
- K210760Precise Image2Cleared 510(K)
- K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition2Cleared 510(K)
- K213096Al-Rad Companion (Pulmonary)2Cleared 510(K)
- K211168Philips Incisive CT on Trailer2Cleared 510(K)
- K211591NAEOTOM Alpha, Scan&GO2Cleared 510(K)
- K212067Deep Learning Image Reconstruction2Cleared 510(K)
- K210085HealthCCSng2Cleared 510(K)
- K211828Aquilion Exceed LB2Cleared 510(K)
- K212494Lung Image Analysis2Cleared 510(K)
- K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software2Cleared 510(K)
- K203448uCT ATLAS with uWS-CT-Dual Energy Analysis2Cleared 510(K)
- K203411syngo.CT Skull Unfolding2Cleared 510(K)
- K203720MICROMATE2Cleared 510(K)
- K203514Precise Position2Cleared 510(K)
- K203699syngo. CT Extended Functionalities2Cleared 510(K)
- K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System2Cleared 510(K)
- K203617MaxFOV 22Cleared 510(K)
- K203020Spectral CT2Cleared 510(K)
- K200626VesselIQ Xpress2Cleared 510(K)
- K201231CTxx85 CT Scanner2Cleared 510(K)
- K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i2Cleared 510(K)
- K202526OmniTom Elite2Cleared 510(K)
- K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I2Cleared 510(K)
- K201745Deep Learning Image Reconstruction for Gemstone Spectral Imaging2Cleared 510(K)
- K203216The Multimodality Advanced Vessel Analysis2Cleared 510(K)
- K203169Revolution Ascend2Cleared 510(K)
- K203187HiRise2Cleared 510(K)
- K193289FastStroke, CT Perfusion 4D2Cleared 510(K)
- K201092LSN2Cleared 510(K)
- K202213syngo.CT Neuro Perfusion2Cleared 510(K)
- K201188Clear Guide SCENERGY2Cleared 510(K)
- K200990VIDAvision2Cleared 510(K)
- K201898Clear Guide SCENERGY2Cleared 510(K)
- K193277SOMATOM On.site and On.scene2Cleared 510(K)
- K200498SCENARIA View2Cleared 510(K)
- K201586XACT Robotic System2Cleared 510(K)
- K193073Deep Recon2Cleared 510(K)
- K201053PercuNav Image Fusion and Interventional Navigation2Cleared 510(K)
- K201034Syngo.CT CaScoring2Cleared 510(K)
- K193293XV Lung Ventilation Analysis Software2Cleared 510(K)
- K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO2Cleared 510(K)
- K200515syngo.CT Cardiac Planning2Cleared 510(K)
- K193281Hepatic VCAR2Cleared 510(K)
- K193267Al-Rad Companion (Musculoskeletal)2Cleared 510(K)
- K192590CURA 7782Cleared 510(K)
- K191550Broncholab2Cleared 510(K)
- K200016uCT 530, uCT 5502Cleared 510(K)
- K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i2Cleared 510(K)
- K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System2Cleared 510(K)
- K193454IQon Spectral CT2Cleared 510(K)
- K192956Auto Positioning2Cleared 510(K)
- K192763syngo.CT CaScoring2Cleared 510(K)
- K193170Deep Learning Image Reconstruction2Cleared 510(K)
- K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO2Cleared 510(K)
- K191891SOMATOM X.cite2Cleared 510(K)
- K192686Revolution Maxima, Revolution Ace2Cleared 510(K)
- K192427Ablation Confirmation2Cleared 510(K)
- K191332XACT Robotic System2Cleared 510(K)
- K192402syngo.CT Extended Functionality2Cleared 510(K)
- K190841SCENARIA View2Cleared 510(K)
- K183268AI-Rad Companion (Cardiovascular)2Cleared 510(K)
- K192188Aquilion ONE (TSX-306A/3) V10.02Cleared 510(K)
- K191394ILLUMISITE Platform2Cleared 510(K)
- K191136Access CT2Cleared 510(K)
- K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition2Cleared 510(K)
- K183271AI-Rad Companion (Pulmonary)2Cleared 510(K)
- K182901Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE2Cleared 510(K)
- K191468syngo.CT Dual Energy2Cleared 510(K)
- K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence2Cleared 510(K)
- K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCE2Cleared 510(K)
- K190505Low Dose Lung Screening Option2Cleared 510(K)
- K182716Brain Perfusion (BP) application2Cleared 510(K)
- K183548SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 162Cleared 510(K)
- K183202Deep Learning Image Reconstruction2Cleared 510(K)
- K183204Bone VCAR (BVCAR)2Cleared 510(K)
- K183448NewTom 5G XL2Cleared 510(K)
- K183161SnapShot Freeze 22Cleared 510(K)
- K183291Supria True64 Whole-Body X-Ray CT System2Cleared 510(K)
- K183143uCT 520, uCT 5282Cleared 510(K)
- K181646Celesteion, PCA-9000A/3, V6.52Cleared 510(K)
- K173076CURA 16; ScintCare CT162Cleared 510(K)
- K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A2Cleared 510(K)
- K182147CTXX852Cleared 510(K)
- K181414uCT 530, uCT 5502Cleared 510(K)
- K181797Philips CT Big Bore Sliding Gantry Configuration2Cleared 510(K)
- K172983HealthCCS2Cleared 510(K)
- K173821LungQ Software2Cleared 510(K)
- K180901Low Dose CT Lung Cancer Screening Option2Cleared 510(K)
- K180727LineUp2Cleared 510(K)
- K180225GSI Viewer with GSI Fat Option2Cleared 510(K)
- K162314IMACTIS CT-Navigation system2Cleared 510(K)
- K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO2Cleared 510(K)
- K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence2Cleared 510(K)
- K173637syngo.CT Coronary Analysis; syngo.CT Vascular Analysis2Cleared 510(K)
- K173607SOMATOM Edge Plus2Cleared 510(K)
- K180015Philips Incisive CT2Cleared 510(K)
- K180393AIRO Computed Tomography (CT) X-ray System2Cleared 510(K)
- K173625syngo.CT Clinical Extensions2Cleared 510(K)
- K172135uCT Computed Tomography X-ray System2Cleared 510(K)
- K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.02Cleared 510(K)
- K172058CT6485, CT128852Cleared 510(K)
- K173244superDimension Navigation System V7.22Cleared 510(K)
- K173478OnSight 3D Extremity System2Cleared 510(K)
- K171677Clear Guide SCENERGY2Cleared 510(K)
- K171198NeuViz 16 Essence Multi-slice CT Scanner System2Cleared 510(K)
- K172539CereTom Elite2Cleared 510(K)
- K163643SIRIO H32Cleared 510(K)
- K171850Philips CT Big Bore2Cleared 510(K)
- K172188Aquilion Prime SP, TSX-303B/1, v8.42Cleared 510(K)
- K171201NeuViz Prime Multi-slice CT Scanner System2Cleared 510(K)
- K171738Supria True642Cleared 510(K)
- K171261ScannerSide DoseCheck2Cleared 510(K)
- K171183OmniTom2Cleared 510(K)
- K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.12Cleared 510(K)
- K170238BodyTom Elite2Cleared 510(K)
- K171013Revolution ACT2Cleared 510(K)
- K170023SPiN Thoracic Navigation System2Cleared 510(K)
- K171022Ablation Confirmation2Cleared 510(K)
- K170789In Reach2Cleared 510(K)
- K170273Z-DOSE292Cleared 510(K)
- K170716PercuNav Image Fusion and Interventional Navigation2Cleared 510(K)
- K170221syngo.CT Cardiac Planning2Cleared 510(K)
- K162838Philips iCT CT System2Cleared 510(K)
- K163711IQon Spectral CT2Cleared 510(K)
- K163297Scan&GO2Cleared 510(K)
- K163296SOMATOM go.Up, SOMATOM go.Now2Cleared 510(K)
- K163528HITACHI Supria Whole-body X-ray CT System Phase 32Cleared 510(K)
- K163284syngo. CT Neuro Perfusion2Cleared 510(K)
- K163341syngo.CT Extended Functionality2Cleared 510(K)
- K163289syngo. CT Single Source Dual Energy (twin beam)2Cleared 510(K)
- K170019Aquilion Lightning, TSX-036A/1, V8.42Cleared 510(K)
- K163281FastStroke2Cleared 510(K)
- K163213Revolution CT2Cleared 510(K)
- K162302Somatom Confidence ® RT Pro2Cleared 510(K)
- K161157Vitrea CT Dual Energy Image View2Cleared 510(K)
- K160723OnSight 3D Extremity System2Cleared 510(K)
- K161196SOMATOM Drive2Cleared 510(K)
- K161748SUPRIA w/guideShot Option2Cleared 510(K)
- K161066SpotLight CT2Cleared 510(K)
- K160743Philips Ingenuity CT2Cleared 510(K)
- K160611P-ARTIS2Cleared 510(K)
- K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.42Cleared 510(K)
- K161285Ablation Confirmation2Cleared 510(K)
- K153360ADMIRE2Cleared 510(K)
- K160350ECG CT Gating Device2Cleared 510(K)
- K160587Aquilion ONE (TSX-305A/3) V7.32Cleared 510(K)
- K153331SafeCT-292Cleared 510(K)
- K160126AIRO Computed Tomography (CT) X-ray System2Cleared 510(K)
- K153444Philips Multislice CT System with Low Dose CT Lung Cancer2Cleared 510(K)
- K153263Aquilion Lightning, TSX-035A/4 and /5, V7.02Cleared 510(K)
- K151765SOMATOM Perspective2Cleared 510(K)
- K151749somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)2Cleared 510(K)
- K153429SmartView 3D Option2Cleared 510(K)
- K153220syngo.CT Single Source Dual Energy (Twin Beam)2Cleared 510(K)
- K153004Clear Guide SCENERGY2Cleared 510(K)
- K152584Stroke VCAR2Cleared 510(K)
- K152473CAS-One IR2Cleared 510(K)
- K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)2Cleared 510(K)
- K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power2Cleared 510(K)
- K151414IQQA Guide2Cleared 510(K)
- K151752SOMATOM Emotion 6/162Cleared 510(K)
- K151376superDimension Navigation System2Cleared 510(K)
- K151383NeuViz 128 Multi-slice CT Scanner System2Cleared 510(K)
- K150713syngo.CT Myocardial Perfusion2Cleared 510(K)
- K151283Lung Analysis Software2Cleared 510(K)
- K150595SCENARIA Phase 3 Whole-body X-ray CT System2Cleared 510(K)
- K151919Vitrea CT Lung Density Analysis Software2Cleared 510(K)
- K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+2Cleared 510(K)
- K151833Aquilion Lightning (TSX-035A/2, V7.0)2Cleared 510(K)
- K150565Supria Whole-body X-ray CT System2Cleared 510(K)
- K151372Low Dose CT Lung Cancer Screening Option for Qualified GE Systems2Cleared 510(K)
- K151533Respiratory Gating for Scanners2Cleared 510(K)
- K150757syngo.CT Dual Energy2Cleared 510(K)
- K150745syngo.CT Single Source Dual Energy2Cleared 510(K)
- K150665Philips Spectral CT Applications2Cleared 510(K)
- K150785syngo.CT Dental2Cleared 510(K)
- K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways2Cleared 510(K)
- K150104Vitrea CT Myocardial Perfusion2Cleared 510(K)
- K143416SOMATOM Definition Flash (VA48)2Cleared 510(K)
- K143400SOMATOM Definition AS/AS+2Cleared 510(K)
- K143401SOMATOM Definition Edge2Cleared 510(K)
- K143409SOMATOM Definition AS Open (VA48)2Cleared 510(K)
- K150003Aquilion LB, TSX-201A/3, V6.02Cleared 510(K)
- K142465Aquilion ONE Vision, v7.02Cleared 510(K)
- K142222NewTom 5G2Cleared 510(K)
- K142584iMAR2Cleared 510(K)
- K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT2Cleared 510(K)
- K142697NExCT 72Cleared 510(K)
- K133373CLEARVIEW2Cleared 510(K)
- K141741AQUILION PRIME, V6.002Cleared 510(K)
- K133674PHILIPS IQON SPECTRAL CT2Cleared 510(K)
- K133643SYNGO, CT LIVER ANALYSIS2Cleared 510(K)
- K133677SYNGO CT SINGLE SOURCE DUAL ENERGY2Cleared 510(K)
- K133603PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION2Cleared 510(K)
- K141069Lung Density Analysis2Cleared 510(K)
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- K974715ADVANTAGE 3D XR2Cleared 510(K)
- K974344CT SCOPE2Cleared 510(K)
- K980837SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS2Cleared 510(K)
- K974513PINPOINT2Cleared 510(K)
- K980176HISPEED QX/I CT SCANNER SYSTEM2Cleared 510(K)
- K980169HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS2Cleared 510(K)
- K974455ANATOM 1000 (A MINUS, A-)2Cleared 510(K)
- K974307RTR-2000/RTR-40002Cleared 510(K)
- K973908AUKLET CT SCANNER, TSX-003A2Cleared 510(K)
- K973168SMARTVIEW OPTIONS FOR HISPEED CT/I2Cleared 510(K)
- K972903IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS2Cleared 510(K)
- K972879ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION2Cleared 510(K)
- K973327SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH2Cleared 510(K)
- K973329SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX2Cleared 510(K)
- K972399ADVANTAGE WINDOWS VOLUME RENDERING OPTION2Cleared 510(K)
- K971717FLY THROUGH2Cleared 510(K)
- K970819TARGOBEAM2Cleared 510(K)
- K971054OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS2Cleared 510(K)
- K970980CARDIAC SCORING FOR CT SCANNERS2Cleared 510(K)
- K970999SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR2Cleared 510(K)
- K970606COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K965004C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER2Cleared 510(K)
- K964890ANATOM 20002Cleared 510(K)
- K964747SOMATOM PLUS 4 CT SCANNER2Cleared 510(K)
- K964746HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION2Cleared 510(K)
- K964583XRT-7.02Cleared 510(K)
- K964318PHILIPS TOMOSCAN AV EXPANDER UPGRADE2Cleared 510(K)
- K963896MOBILE CT PROSPEED FAMILY2Cleared 510(K)
- K960985SLS-CT2Cleared 510(K)
- K961464SELECT/SP2Cleared 510(K)
- K961055CT PROSPEED CT/I2Cleared 510(K)
- K955583VIFS2Cleared 510(K)
- K950972REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A2Cleared 510(K)
- K960635PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS2Cleared 510(K)
- K955255SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX2Cleared 510(K)
- K955268PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K955254SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC2Cleared 510(K)
- K955253SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH2Cleared 510(K)
- K935454DPX TISSUE QUANTIFICATION OUTPUT2Cleared 510(K)
- K954255PHILIPS TOMOSCAN SR 80002Cleared 510(K)
- K943623PQ5000 CT SYSTEM2Cleared 510(K)
- K945512HRSW OPTION FOR CT TWIN FLASH2Cleared 510(K)
- K944013CT PROSPEED FAMILY2Cleared 510(K)
- K944131ANATOM 20002Cleared 510(K)
- K944983MEDRAD COUNTERPOISE SYSTEM2Cleared 510(K)
- K944326PHILIPS TOMOSCAN SR50002Cleared 510(K)
- K936272PHILIPS TOMOSCAN SR 40002Cleared 510(K)
- K941546SOMATOM PROJECT 0592Cleared 510(K)
- K940606HISPEED ADVANTAGE II2Cleared 510(K)
- K941745TSX-002A (XVISION) CT SCANNER2Cleared 510(K)
- K932508ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW2Cleared 510(K)
- K942040MRX-2802Cleared 510(K)
- K935487SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF2Cleared 510(K)
- K923524VOLUMETRIC RENDERING TECHNIQUE OPTION2Cleared 510(K)
- K924985COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION2Cleared 510(K)
- K932848SIMULIX-MC CT EXTENSION2Cleared 510(K)
- K934832IMPAX 30002Cleared 510(K)
- K930765ULTRA COMPACT VIDEO IMAGER2Cleared 510(K)
- K930090HELICAT2Cleared 510(K)
- K924082PHILIPS TOMOSCAN SR7000 CT SYSTEMS2Cleared 510(K)
- K923077ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION2Cleared 510(K)
- K924810SIM/PLANT2Cleared 510(K)
- K921192CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM2Cleared 510(K)
- K923114HEAD RESTRAINT FOR CT TABLES2Cleared 510(K)
- K923110SCAN BAND2Cleared 510(K)
- K923109ADULT CHIN STRAP FOR CT TABLES2Cleared 510(K)
- K923108WRIST RESTRAINT FOR GE9800 C.T. TABLES2Cleared 510(K)
- K923111ARM EXTENDER FOR CT TABLES2Cleared 510(K)
- K923106SCAN BAND2Cleared 510(K)
- K915738EXCEL CT TWIN2Cleared 510(K)
- K921432SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF2Cleared 510(K)
- K914305SYTEC DENTASCAN2Cleared 510(K)
- K915623SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE2Cleared 510(K)
- K913485CT SYTEC 80002Cleared 510(K)
- K913352C-150 ULTRAFAST CT SCANNER2Cleared 510(K)
- K913996COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION2Cleared 510(K)
- K913029GYROVIEW-HR2Cleared 510(K)
- K912454KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE2Cleared 510(K)
- K911764IMAC20002Cleared 510(K)
- K913491VORTECH'S PERSONAL DISPLAY SYSTEM2Cleared 510(K)
- K912752PHILIPS TOMOSCAN SR2Cleared 510(K)
- K913252LITEBOX2Cleared 510(K)
- K911501SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX2Cleared 510(K)
- K911500SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH2Cleared 510(K)
- K910859COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K911387CT SYTEC 40002Cleared 510(K)
- K910375HELICAL SCAN2Cleared 510(K)
- K904971CT HILIGHT ADVANTAGE II2Cleared 510(K)
- K903701XPRESS2Cleared 510(K)
- K903763COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K903622CT GUIDE (TM)2Cleared 510(K)
- K902557XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K902848FASTRECON 88 PERIFERAL2Cleared 510(K)
- K900170MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U2Cleared 510(K)
- K902643FALCON DISK DRIVE SUBSYSTEM2Cleared 510(K)
- K900660TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE2Cleared 510(K)
- K896456TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K900233TCT-300S - UPGRADE2Cleared 510(K)
- K894888SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE2Cleared 510(K)
- K894887SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF2Cleared 510(K)
- K894542ELSCINT'S EXEL 2400E CT SCANNER2Cleared 510(K)
- K894269CT HILIGHT ADVANTAGE2Cleared 510(K)
- K893820CT SYTEC 30002Cleared 510(K)
- K891931QCT-LUNG NODULE (TM) ANALYSIS PACKAGE2Cleared 510(K)
- K884788TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K884555TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM2Cleared 510(K)
- K8853223D/DENTAL2Cleared 510(K)
- K884670EXEL 1800 AND 1800E CT SCANNER2Cleared 510(K)
- K884671EXEL 2400 AND 2400 ELITE CT SCANNERS2Cleared 510(K)
- K884667EXEL 905 SERIES CT SCANNER2Cleared 510(K)
- K884669EXEL 2002 & 2002FS CT SCANNER2Cleared 510(K)
- K884668EXEL 1002 CT SCANNER2Cleared 510(K)
- K884268VOXELSCOPE(TM)2Cleared 510(K)
- K881305TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM2Cleared 510(K)
- K882378P-7 COMPUTED TOMOGRAPHY SYSTEM2Cleared 510(K)
- K881674SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC2Cleared 510(K)
- K882906DENTASCAN2Cleared 510(K)
- K882581CT MAX 640 #B7940 JA/JE2Cleared 510(K)
- K882022TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM2Cleared 510(K)
- K875088XENON CT2Cleared 510(K)
- K875370SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX2Cleared 510(K)
- K880965SOMATOM PLUS2Cleared 510(K)
- K880822PICS-20002Cleared 510(K)
- K874767SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-112Cleared 510(K)
- K872615IMATRON C-100 ULTRAFAST CT SCANNER2Cleared 510(K)
- K872526CT PACE CATALOG NUMBER B7950A2Cleared 510(K)
- K872150I.S.G. 3DMV WORKSTATION2Cleared 510(K)
- K871859CT9800 QUICK 3D #B7919DA2Cleared 510(K)
- K870513CSI/3D2Cleared 510(K)
- K863935TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY2Cleared 510(K)
- K864046C-IOO MOBILE CINE CT UNIT2Cleared 510(K)
- K862317CT MAX, CATALOG NO. B7940 HA2Cleared 510(K)
- K861698VISISCAN CT SCANNERS - MODELS V600, V1200 & V24002Cleared 510(K)
- K861708SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC2Cleared 510(K)
- K854340TECHNICARE 720 HPS CT SCANNER2Cleared 510(K)
- K853444TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS2Cleared 510(K)
- K852865OPTICAL DISC UNIT2Cleared 510(K)
- K844926HEAD-SPINE STABILIZER HSS-12Cleared 510(K)
- K850027MEDITECH EUROSCANNER M2502Cleared 510(K)
- K843927CT 90002Cleared 510(K)
- K841997CT 98002Cleared 510(K)
- K840860CENTAURI CT SCANNER2Cleared 510(K)
- K833228INSTANT IMAGER2Cleared 510(K)
- K820688ARRANGE TM2Cleared 510(K)
- K813196IMAGE ANALYSIS CENTER2Cleared 510(K)
- K813162INTERAD WHOLE BODY CT SCANNER2Cleared 510(K)
- K812509CT/T 88002Cleared 510(K)
- K8123934001 CT SCANNER2Cleared 510(K)
- K812410DELTASCAN 2060 CT SCANNER2Cleared 510(K)
- K812400OMNIMEDICAL QUAD I2Cleared 510(K)
- K812241CT/T 98002Cleared 510(K)
- K811723WHOLE BODY SCANNER2Cleared 510(K)
- K811227CT/T DATALINK-B7875 AA/B7875 AB2Cleared 510(K)
- K811358DEHYDRATED BILE2Cleared 510(K)
- K803181SCANNER, COMPUTERIZED TOMOGRAPHIC2Cleared 510(K)
- K802206OMNI SCANNER CT 60002Cleared 510(K)
- K802045G.E. SCAN CAPABILITY CAT.#B7815F2Cleared 510(K)
- K801446PFIZER PZ-CT SCANNER2Cleared 510(K)
- K801407SYNERVIEW MODEL 65452Cleared 510(K)
- K792603COMPUTED TOMOGRAPHY X-RAY SCANNER2Cleared 510(K)
- K791163PFIZER 0200FS LOCALLZER2Cleared 510(K)
- K791153ACTA-SCANNER 0220FS2Cleared 510(K)
- K791195DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN2Cleared 510(K)
- K790975SOMATOM 22Cleared 510(K)
- K790942RADVIEW IMAGER SYSTEM2Cleared 510(K)
- K790395VIDICAM VIDEO REPROGRAPH2Cleared 510(K)
- K790342SOMATOM SD2Cleared 510(K)
- K790134RADIOTHERAPY TREATMENT2Cleared 510(K)
- K781936SCANNER-EMI 7020 AND 7020R2Cleared 510(K)
- K781752SCANNER, CT 04502Cleared 510(K)
- K781431ELECTRIC CT/T OPERATOR DISPLAY CONSOLE2Cleared 510(K)
- K781040CT SCANNER ND 80002Cleared 510(K)
- K7809305543 INDEPENDENT VIEWING SYSTEM2Cleared 510(K)
- K780928CT5137 HIGH RESOLUTION OPTION2Cleared 510(K)
- K780769S-100 CT SCANNER2Cleared 510(K)
- K780737CT BLANKETS (BOLUS MATERIAL)2Cleared 510(K)
- K780480CT/T INDEPENDENT DIAGNOSTIC CENTER2Cleared 510(K)
- K780326GE CT/T 8800 SYSTEM2Cleared 510(K)
- K780115SCANNERS, TOMOGRAPHIC, COMPUTED2Cleared 510(K)
- K772317CT/T SYSTEM MODEL B7800A2Cleared 510(K)
- K772305RAD. THERAPY PLANNING SUP. SYS.2Cleared 510(K)
- K772291DIAG. CONSOLE, INDEPENDENT2Cleared 510(K)
- K772289SCANNER, CT, 04002Cleared 510(K)
- K772198CT SCANNER DIAGNOSTIC CONSOLE, REMOTE2Cleared 510(K)
- K771990OMNIMEDICAL 400L2Cleared 510(K)
- K771978CTR 100L2Cleared 510(K)
- K772123TOMOGRAPHIC SYSTEM, COMPUTERIZED2Cleared 510(K)
- K772125TOMOGRAPHIC SCANNER, COMPUTERIZED2Cleared 510(K)
- K771811EMI CTR 1002Cleared 510(K)
- K771082DELTASCAN 2000 SERIES2Cleared 510(K)
- K770855SYNERVIEW MODEL 64782Cleared 510(K)
- K770573ACTA-SCANNER R 0200FS2Cleared 510(K)
- K761332HI-SENSITIVITY MODE OPTION FOR S60-1A2Cleared 510(K)
- K761330SYNTEX SYSTEM 60002Cleared 510(K)
- K761033COMPUTERIZED TOMOGRAPHY SCANNER2Cleared 510(K)
- K760882GE CT/T MODEL NO. B7800 A2Cleared 510(K)
- K760808PHO. TRAX MODEL 4000 WHOLE BODY SCAN.2Cleared 510(K)
- K760688CT/N-II SCANNER SYSTEM2Cleared 510(K)
- K760201X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC2Cleared 510(K)
- 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
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2Product Code
- MUABone Sonometer2Product Code
- MUEFull Field Digital, System, X-Ray, Mammographic2Product Code
- MUIMedia, Coupling, Ultrasound2Product Code
- MWPCabinet, X-Ray System2Product Code
- MYNAnalyzer, Medical Image2Product Code
- NCSSystem, Imaging, Holography, Acoustic2Product Code
- NWEColon Computed Tomography System, Computer Aided Detection2Product Code
- OASX-Ray, Tomography, Computed, Dental2Product Code
- OEBLung Computed Tomography System, Computer-Aided Detection2Product Code
- OIIArthrogram Tray2Product Code
- OIJBiopsy Needle Guide Kit2Product Code
- OIKRadiology Dental Tray2Product Code
- OILDiscography Kit2Product Code
- OIMMri Disposable Kit2Product Code
- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
- OQQDiagnostic Ultrasonic Transducer, Robotic2Product Code
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2Product Code
- OWBInterventional Fluoroscopic X-Ray System2Product Code
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QFMRadiological Computer-Assisted Prioritization Software For Lesions2Product Code
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2Product Code
- QHXFluoroscopic X-Ray Image Intensifier1Product Code
- QHYSolid State Fluoroscopic X-Ray Imager2Product Code
- QIHAutomated Radiological Image Processing Software2Product Code
- QKBRadiological Image Processing Software For Radiation Therapy2Product Code
- RCCC-Arm Fluoroscopic X-Ray System2Product Code
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2Product Code
- QXLCabinet, Emission Computed Tomography System2Product Code
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
FCT iSTREAM Phase 1
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K233583
- 510(k) Type
- Traditional
- Applicant
- FUJIFILM Healthcare Americas Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/26/2024
- Days to Decision
- 171 days
- Submission Type
- Summary