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
- K252477Hybrid Viewer (00859873006240)2Cleared 510(K)
- K250170PHAROS2Cleared 510(K)
- K251561Biograph Trinion2Cleared 510(K)
- K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)2Cleared 510(K)
- K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems2Cleared 510(K)
- K251153Aurora2Cleared 510(K)
- K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 42Cleared 510(K)
- K241266Imaging system of positron emission and X-ray computed tomography (DigitMI 930)2Cleared 510(K)
- K243605Aurora2Cleared 510(K)
- K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)2Cleared 510(K)
- K241364Hybrid Viewer (00859873006189)2Cleared 510(K)
- K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family2Cleared 510(K)
- K241585uMI Panorama2Cleared 510(K)
- K241596uMI Panvivo2Cleared 510(K)
- K241665Omni Legend2Cleared 510(K)
- K241898Symbia SPECT and SPECT/CT Systems2Cleared 510(K)
- K241751NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat2Cleared 510(K)
- K240827SET-50022Cleared 510(K)
- K231762uEXPLORER2Cleared 510(K)
- K233677Biograph VK102Cleared 510(K)
- K232712uMI Panorama2Cleared 510(K)
- K232569CAREMIBRAIN2Cleared 510(K)
- K231576cNeuro cPET2Cleared 510(K)
- K231748Cartesion Prime (PCD-1000A/3) V10.152Cleared 510(K)
- K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 42Cleared 510(K)
- K231572uMI Panorama2Cleared 510(K)
- K231833Biograph Vision.X and Biograph Vision.X Edge2Cleared 510(K)
- K231102Symbia Pro.specta VA20A Family2Cleared 510(K)
- K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)2Cleared 510(K)
- K223212Precision DL2Cleared 510(K)
- K223422Emory Cardiac Toolbox 4.32Cleared 510(K)
- K223325uMI Panorama2Cleared 510(K)
- K223547Biograph Vision Quadra PET/CT System2Cleared 510(K)
- K222895DynamicIQ2Cleared 510(K)
- K221932Omni Legend2Cleared 510(K)
- K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows2Cleared 510(K)
- K214062Radialis PET Camera2Cleared 510(K)
- K211964SubtlePET2Cleared 510(K)
- K212604Symbia VA10A Family2Cleared 510(K)
- K212004MyoSPECT, MyoSpect ES2Cleared 510(K)
- K211846Discovery MI Gen22Cleared 510(K)
- K211764Vereos PET/CT2Cleared 510(K)
- K211247PET VCAR2Cleared 510(K)
- K210880Vereos PET/CT2Cleared 510(K)
- K210557Symbia VA10A Family2Cleared 510(K)
- K210001HYPER AiR2Cleared 510(K)
- K203314Cartesion Prime (PCD-1000A/3) V10.82Cleared 510(K)
- K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 32Cleared 510(K)
- K210418HYPER Focus2Cleared 510(K)
- K210173StarGuide2Cleared 510(K)
- K210450BBX-PET Scanner2Cleared 510(K)
- K210262Biograph Vision Quadra PET/CT System2Cleared 510(K)
- K202882Affinity2Cleared 510(K)
- K202392SIR-Spheres Microspheres Activity Calculator (SMAC)2Cleared 510(K)
- K202349Cartesion Prime, PCD-1000A, V10.72Cleared 510(K)
- K201807ANCORIS2Cleared 510(K)
- K201933ImagenSPECT 3.02Cleared 510(K)
- K193210HYPER DLR2Cleared 510(K)
- K200474Symbia 6.72Cleared 510(K)
- K193248Biograph Vision, Biograph mCT Family of PET/CTs2Cleared 510(K)
- K193152Affinity2Cleared 510(K)
- K192277CardIQ Flow2Cleared 510(K)
- K193178Biograph Horizon2Cleared 510(K)
- K193241Emission Computed Tomography System2Cleared 510(K)
- K191582Cartesion Prime2Cleared 510(K)
- K190457VERITON CT whole body SPECT/CT system2Cleared 510(K)
- K190900Biograph Vision2Cleared 510(K)
- K182938Emission Computed Tomography System2Cleared 510(K)
- K182336SubtlePET2Cleared 510(K)
- K182484VERITON CT whole body SPECT/CT system2Cleared 510(K)
- K181468Hybrid3D2Cleared 510(K)
- K182237uMI 550 PET/CT System2Cleared 510(K)
- K180077NeuroQ 3.82Cleared 510(K)
- K181343HeartSee Cardiac P.E.T. Processing Software2Cleared 510(K)
- K180811Biograph Vision2Cleared 510(K)
- K180514VERITON NM2Cleared 510(K)
- K173816NM/CT 850, NM/CT 8602Cleared 510(K)
- K172143uMI 780 PET/CT System2Cleared 510(K)
- K180318PET Digital Gating2Cleared 510(K)
- K173547ImagenUniversal2Cleared 510(K)
- K173578Biograph mCT Family of PET/CT Systems2Cleared 510(K)
- K171719Hybrid3D2Cleared 510(K)
- K171681Hermes Medical Imaging Suite v5.72Cleared 510(K)
- K173023Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold2Cleared 510(K)
- K172609CSMC Cardiac Suite2Cleared 510(K)
- K172406Ingenuity TF2Cleared 510(K)
- K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K1436642Cleared 510(K)
- K170904Biograph Horizon PET/CT2Cleared 510(K)
- K170490Celesteion, PCA-9000A/32Cleared 510(K)
- K163394Hybrid3D2Cleared 510(K)
- K162483Symbia Intevo Bold2Cleared 510(K)
- K161740D-SPECT Scanner, D-SPECT L Scanner2Cleared 510(K)
- K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT2Cleared 510(K)
- K161674QuantumCam2Cleared 510(K)
- K162337Symbia 6.52Cleared 510(K)
- K161574Discovery MI2Cleared 510(K)
- K161631MAMMI2Cleared 510(K)
- K153056Hermes Medical Imaging Suite v5.62Cleared 510(K)
- K160120D-SPECT Processing and Reviewing Workstation2Cleared 510(K)
- K152503ImagenSPECT2Cleared 510(K)
- K153402Discovery NM/CT 670 CZT2Cleared 510(K)
- K152880Biograph Horizon PET/CT2Cleared 510(K)
- K151403Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System2Cleared 510(K)
- K151486Biograph mCT and mCT Flow PET/CT Scanners2Cleared 510(K)
- K143664HeartSee2Cleared 510(K)
- K142631Hermes Medical Imaging Suite v5.52Cleared 510(K)
- K141477DISCOVERY IQ2Cleared 510(K)
- K141074CORTEX ID SUITE2Cleared 510(K)
- K141971BIOGRAPH TRUE PET/CT FAMILY SOFTWARE2Cleared 510(K)
- K142006SYMBIA 6.02Cleared 510(K)
- K141652CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE2Cleared 510(K)
- K140996MAMMI2Cleared 510(K)
- K140651CELESTEION, PCA-9000A/22Cleared 510(K)
- K140269HERMES MEDICAL IMAGING SUITE V5.42Cleared 510(K)
- K140206SCINTILLATION GAMMA CAMERA2Cleared 510(K)
- K133657DISCOVERY PET/CT 7102Cleared 510(K)
- K132347MULTICAM 3000 ECO2Cleared 510(K)
- K131625ANYSCAN-S SPECT IMAGING SYSTEM2Cleared 510(K)
- K131634SYMBIA2Cleared 510(K)
- K131233HERMES MEDICAL IMAGING SUITE V5.32Cleared 510(K)
- K123599INGENUITY DIGITAL PET/CT2Cleared 510(K)
- K130902EMORY CARDIAC TOOLBOX 3.22Cleared 510(K)
- K130451NEUROQ 3.62Cleared 510(K)
- K130269ECAT SCINTRON PET2Cleared 510(K)
- K123433CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE2Cleared 510(K)
- K123646EMORY CARDIAC TOOLBOX 4.02Cleared 510(K)
- K123737BIOGRAPH MCT FAMILY2Cleared 510(K)
- K121278HERMES MEDICAL IMAGING SUITE V5.22Cleared 510(K)
- K122241IMAGEN3D2Cleared 510(K)
- K113754CFR QUANT2Cleared 510(K)
- K121019OPTIMA NM/CT 6402Cleared 510(K)
- K113408Q. FREEZE (MOTION VUE2)2Cleared 510(K)
- K113086ACQA2Cleared 510(K)
- K113448BIOGRAPH MCT FAMILY2Cleared 510(K)
- K113350BRIVO NM 6152Cleared 510(K)
- K112474CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE2Cleared 510(K)
- K110507CARDIAC SCANNER AND PROCESSING SYSTEM2Cleared 510(K)
- K111445DISCOVERY NM 6302Cleared 510(K)
- K100714CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-012Cleared 510(K)
- K103710WBR XPRESS PET2Cleared 510(K)
- K101768MIE SCINTRON GAMMA CAMERA SYSTEMS2Cleared 510(K)
- K101550BIOGRAPH MCT FAMILY2Cleared 510(K)
- K101013MODIFICATION TO SCINTRON IV2Cleared 510(K)
- K093514DISCOVERY MODEL NM/CT 6702Cleared 510(K)
- K090811INSPIRA HD, MODEL: NL10002Cleared 510(K)
- K091073WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS2Cleared 510(K)
- K091269NEUROPET2Cleared 510(K)
- K090178ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P82Cleared 510(K)
- K090553NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER2Cleared 510(K)
- K090403AUTOSPECT2Cleared 510(K)
- K083852BIOGRAPH 16 TRUE POINT SYSTEMS2Cleared 510(K)
- K083649CARDIUS 3 X-ACT2Cleared 510(K)
- K082904STASYS MOTION CORRECTION SOFTWARE2Cleared 510(K)
- K083504GE DISCOVERY NM/CT 570C2Cleared 510(K)
- K082506SYMBIA, VERSION 4.02Cleared 510(K)
- K082354STEREO NAVIGATOR ACCESSORY, STN-10002Cleared 510(K)
- K082581C-QUEST2Cleared 510(K)
- K082368CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM2Cleared 510(K)
- K082244PCA-8000A, MARK 11, PET / CT SYSTEM2Cleared 510(K)
- K081453BIOGRAPH HD FAMILY2Cleared 510(K)
- K081496OPTIMA PET/CT 5602Cleared 510(K)
- K081426NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE2Cleared 510(K)
- K081201WBR XPRESS3.CARDIAC2Cleared 510(K)
- K080575CORRIDOR4DM2Cleared 510(K)
- K081135GEMINI CONDOR2Cleared 510(K)
- K080927BRIGHTVIEW VCT IMAGING SYSTEM2Cleared 510(K)
- K080784WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE2Cleared 510(K)
- K072307QUANTITATIVE NEUROQ 3.02Cleared 510(K)
- K080124VENTRI 1.12Cleared 510(K)
- K073021MULTI-SPECT2Cleared 510(K)
- K072567SYMBIA-E, MODEL 102758792Cleared 510(K)
- K072191CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM2Cleared 510(K)
- K072468MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM2Cleared 510(K)
- K071503SYSTEM, TOMOGRAPHY, COMPUTED EMISSION2Cleared 510(K)
- K071068BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 102381972Cleared 510(K)
- K070589C!2Cleared 510(K)
- K070542CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS2Cleared 510(K)
- K062450D-SPECT CARDIAC SCANNER SYSTEM2Cleared 510(K)
- K062393GE VANTAGE PET NEURO SOFTWARE2Cleared 510(K)
- K062298APOLLO GAMMA CAMERA SYSTEM2Cleared 510(K)
- K061545SCENIUM 1.12Cleared 510(K)
- K061587FULLCARD ANALYSIS2Cleared 510(K)
- K060486CYCLONE, MODEL MAICAM 1802Cleared 510(K)
- K060631BIOGRAPH 64 AND BIOGRAPH 402Cleared 510(K)
- K060060BIOGRAPH 62Cleared 510(K)
- K053086MIE - GAMMA CAMERA SYSTEMS2Cleared 510(K)
- K060020AUTOQUANT PLUS2Cleared 510(K)
- K053062CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV22Cleared 510(K)
- K052640GEMINI RAPTOR2Cleared 510(K)
- K052430CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM2Cleared 510(K)
- K052434HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA2Cleared 510(K)
- K051855VENTRI2Cleared 510(K)
- K051549CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM2Cleared 510(K)
- K051460C.CAM-AC2Cleared 510(K)
- K051351PRECEDENCE SPECT/CT IMAGING SYSTEM2Cleared 510(K)
- K051170GEMINI GXL2Cleared 510(K)
- K050815XACT.CARDIAC & XPRESS.CARDIAC2Cleared 510(K)
- K050509LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I2Cleared 510(K)
- K050559GE DISCOVERY VCT SYSTEM2Cleared 510(K)
- K050366IMAGENPRO2Cleared 510(K)
- K043441MIRAGE, RELEASE 5.52Cleared 510(K)
- K043381INFINIA LIGHTSPEED2Cleared 510(K)
- K043293MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U2Cleared 510(K)
- K042863SCENIUM2Cleared 510(K)
- K042935GEMINI GXL2Cleared 510(K)
- K042880JETSTREAM WORKSPACE2Cleared 510(K)
- K042903AUTOSPECS2Cleared 510(K)
- K042839C-PET PLUS IMAGING SYSTEM2Cleared 510(K)
- K042258BP-SPECT V1.O2Cleared 510(K)
- K042467LSO PET/CT HIREZ 642Cleared 510(K)
- K042428SCEPTREP3 PET/CT2Cleared 510(K)
- K042257DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION2Cleared 510(K)
- K041840MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM2Cleared 510(K)
- K041955GEMINI PET/CT IMAGING SYSTEM2Cleared 510(K)
- K041671IMAGENMD2Cleared 510(K)
- K041543GE DISCOVERY ST2Cleared 510(K)
- K041022NEUROQ - PET DP2Cleared 510(K)
- K041220GE DISCOVERY ST SYSTEM2Cleared 510(K)
- K040933ECAT HRRT2Cleared 510(K)
- K041218GRIFFIN SPECT/CT IMAGING SYSTEM2Cleared 510(K)
- K041182SYNTEGRA2Cleared 510(K)
- K041166SIEMENS ENHANCED IMAGING SYSTEM2Cleared 510(K)
- K040172MODIFICATION TO GE DISCOVERY LS SYSTEM2Cleared 510(K)
- K040616CARDIOMD-AC2Cleared 510(K)
- K040370WBR-FHR, WBR-FWB2Cleared 510(K)
- K040326AUTOQUANT PLUS2Cleared 510(K)
- K040057MOBILE COMPACT DIGITAL CARDIAC CAMERA2Cleared 510(K)
- K040141EMORY CARDIAC TOOLBOX VERSION 2.62Cleared 510(K)
- K033956MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)2Cleared 510(K)
- K033874MYOLIGHT2Cleared 510(K)
- K033001APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-42Cleared 510(K)
- K033782ALLEGRO IMAGING SYSTEM2Cleared 510(K)
- K032779MODIFICATION TO: NUCAMMA RX2Cleared 510(K)
- K033735VANTAGE PRO ATTENUATION CORRECTION DEVICE2Cleared 510(K)
- K032866CLARITY PET2Cleared 510(K)
- K033431LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ2Cleared 510(K)
- K033199COMPACT DIGITAL CARDIAC CAMERA (CDCC)2Cleared 510(K)
- K033254FORTE GAMMA CAMERA SYSTEM2Cleared 510(K)
- K032500MODIFICARION TO WACKERS-LIU CQ SOFTWARE2Cleared 510(K)
- K032063PEM 2400 PET SCANNER2Cleared 510(K)
- K031874MODIFICATION TO WBR, MODEL HR2Cleared 510(K)
- K032036GEMINI 162Cleared 510(K)
- K031872ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]2Cleared 510(K)
- K031825C.CAM2Cleared 510(K)
- K031705SKYLIGHT IMAGING SYSTEM2Cleared 510(K)
- K030870WBR, MODEL HR2Cleared 510(K)
- K030199GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM2Cleared 510(K)
- K030085CARDIUS-1 AND CARDIS-22Cleared 510(K)
- K023988GE DISCOVERY LS SYSTEM2Cleared 510(K)
- K023932GE PHOTON ENERGY RECOVERY (PER) OPTION2Cleared 510(K)
- K023768ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 162Cleared 510(K)
- K023110CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 1110052Cleared 510(K)
- K023518ECAT LSO PET/CT 162Cleared 510(K)
- K022960GE QUASAR NUCLEAR MEDICINE SYSTEM2Cleared 510(K)
- K022872GE ROAD WARRIOR PET CT IMAGING SYSTEM2Cleared 510(K)
- K021633ECAT VISION PET SCANNER, MODELS 3000 & 50002Cleared 510(K)
- K022240MOBILE MILLENNIUM MG SYSTEM2Cleared 510(K)
- K022001MPOWER, MODEL 712 SERIES2Cleared 510(K)
- K021823CARDIOSPECT D90/CARDIO CAM2Cleared 510(K)
- K021656HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.42Cleared 510(K)
- K020300NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)2Cleared 510(K)
- K013353NEUROSPECTQUAD GAMMA CAMERA2Cleared 510(K)
- K014033EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS2Cleared 510(K)
- K013667BCC GAMMA CAMERA2Cleared 510(K)
- K013496MODIFICATION TO SKYLIGHT IMAGING SYSTEM2Cleared 510(K)
- K013504MODIFICATION TO: ECAT LSO PET/CT SCANNER2Cleared 510(K)
- K012775GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER2Cleared 510(K)
- K012568GE VISION NUCLEAR MEDICINE WORKSTATION2Cleared 510(K)
- K011572QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)2Cleared 510(K)
- K011611CARDIOCAM MODEL 9CSY07992Cleared 510(K)
- K010509CEDARS-SINAI BPGS AND MOCO2Cleared 510(K)
- K003882NUCAMMA BI902Cleared 510(K)
- K010137ORBITER II CCI/SPECT ORBITER II CCI/SPECT2Cleared 510(K)
- K003358QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)2Cleared 510(K)
- K003849GE ADVANCE NXI PET SYSTEM2Cleared 510(K)
- K003264QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION2Cleared 510(K)
- K003241ECAT PET SCANNER2Cleared 510(K)
- K003434ALLEGRO TB, ALLEGRO N2Cleared 510(K)
- K002584ECAT ACCEL PET SCANNER2Cleared 510(K)
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- K983516TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A2Cleared 510(K)
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- K972686VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER2Cleared 510(K)
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- K972509CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER2Cleared 510(K)
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- K971878VANTAGE 2.1 EXSPECT2Cleared 510(K)
- K970970CARDIOMATCH2Cleared 510(K)
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- K961577PRISM 3000XPV SYSTEM (210714)2Cleared 510(K)
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- K952684VERTEX EPIC MCD2Cleared 510(K)
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- K942145NON-UNIFORM ATTENUATION CORRECTION SYSTEM2Cleared 510(K)
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- K941223ADVANCE ANALYSIS SOFTWARE2Cleared 510(K)
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- K940236QUANTITATIVE HEART2Cleared 510(K)
- K940300MAGELLAN2Cleared 510(K)
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- K933321DELTAMANAGER2Cleared 510(K)
- K933446PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS)2Cleared 510(K)
- K933372VISIONLINK INTERFILE CONVERSION SOFTWARE2Cleared 510(K)
- K932745C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)2Cleared 510(K)
- K931297GCA-7200A2Cleared 510(K)
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- K931193SIM-400 SYSTEM2Cleared 510(K)
- K930428PENN-PET SCANNER2Cleared 510(K)
- K926133CORT-EX2Cleared 510(K)
- K925330SYSTEM, TOMOGRAPHIC, NUCLEAR2Cleared 510(K)
- K925186EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS2Cleared 510(K)
- K922303M-LINK2Cleared 510(K)
- K924877OPTITRACK2Cleared 510(K)
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- K923345BIAD NEW DETECTOR OPTION2Cleared 510(K)
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- K922373MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM2Cleared 510(K)
- K922372MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM2Cleared 510(K)
- K921777CARDIAC FIRST PASS ANALYSIS2Cleared 510(K)
- K922671CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS2Cleared 510(K)
- K920958SUMMIT NUCLEAR VISION NEUROSPECT2Cleared 510(K)
- K922080GENESYS II2Cleared 510(K)
- K914267GE 4096 PLUS & GE 20482Cleared 510(K)
- K922313P-LINK2Cleared 510(K)
- K921008VECTOR SERIES2Cleared 510(K)
- K920776CARDIAC TRIAD NUCLEAR IMAGING SYSTEM2Cleared 510(K)
- K920624ECAT EXACT HR MODEL 9612Cleared 510(K)
- K915470OPTIMA NUCLEAR TOMOGRAPHY STYSTEM2Cleared 510(K)
- K915644CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS2Cleared 510(K)
- K914807APEX HELIX - A2Cleared 510(K)
- K913641SOPHY NXT2Cleared 510(K)
- K914296CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC2Cleared 510(K)
- K913637ECAT SCANNER (MODEL 921)2Cleared 510(K)
- K914527CEQUAL(TM)2Cleared 510(K)
- K914179CARDIOFOCAL COLLIMATOR2Cleared 510(K)
- K912573VISION (NUCLEAR MEDICINE COMPUTER)2Cleared 510(K)
- K913630MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM2Cleared 510(K)
- K913471CIRRUS GAMMA CAMERA2Cleared 510(K)
- K912177VISIONPRO2Cleared 510(K)
- K912176ACQUPRO2Cleared 510(K)
- K911290EAGLE NUCLEAR IMAGING SYSTEM2Cleared 510(K)
- K911078MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM2Cleared 510(K)
- K910048ECAT SCANNER2Cleared 510(K)
- K911275POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM2Cleared 510(K)
- K896151EMISSION TOMOGRAPHY CAROUSEL2Cleared 510(K)
- K900892MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE2Cleared 510(K)
- K901019DIACAM GAMMA CAMERA SYSTEM2Cleared 510(K)
- K896458ASPECT GAMMA CAMERA2Cleared 510(K)
- K894056POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W2Cleared 510(K)
- K894998MODIFIED POSICAM SYSTEM MODEL 6.52Cleared 510(K)
- K892358PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER2Cleared 510(K)
- K892875BIAD NUCLEAR IMAGING SYSTEM2Cleared 510(K)
- K891266NEUROFOCAL COLLIMATOR2Cleared 510(K)
- K890100PENN-PET SCANNER2Cleared 510(K)
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- K875378SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION2Cleared 510(K)
- K873775TRIAD NUCLEAR IMAGING SYSTEM2Cleared 510(K)
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- K861252NON-CIRCULAR ORBITING OPTION2Cleared 510(K)
- K850416TOMOMATIC 5642Cleared 510(K)
- K852239POSICAM TM(MODEL 3.2,4.3,6.5)2Cleared 510(K)
- K843366SUPERPETT2Cleared 510(K)
- K810589NEURO-ECAT2Cleared 510(K)
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- K791055ADAC TOMOGRAPHY OPTION2Cleared 510(K)
- K790169TOMOGRAPHIC PROGRAMS2Cleared 510(K)
- K781753TOMOGSCANNER 22Cleared 510(K)
- K770220RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.2Cleared 510(K)
- 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
- 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
SIR-Spheres Microspheres Activity Calculator (SMAC)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K202392
- 510(k) Type
- Traditional
- Applicant
- Sirtex Medical US Holdings Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/23/2020
- Days to Decision
- 63 days
- Submission Type
- Summary