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
- K231986Modus IR2Cleared 510(K)
- K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)2Cleared 510(K)
- K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)2Cleared 510(K)
- K230727SPY Portable Handheld Imaging (SPY-PHI) System2Cleared 510(K)
- K222240EXPLORER AIR® II2Cleared 510(K)
- K214097Explorer Air II2Cleared 510(K)
- K202391DIR 8002Cleared 510(K)
- K192761Asimov-MKS Imaging System2Cleared 510(K)
- K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IR2Cleared 510(K)
- K182907SPY Elite Intraoperative Perfusion Assessment System2Cleared 510(K)
- K181537GLOW8002Cleared 510(K)
- K180019CAAS Workstation2Cleared 510(K)
- K162991YELLOW 560 Fluorescence Module2Cleared 510(K)
- K170239Leica FL5602Cleared 510(K)
- K151780CAAS Workstation2Cleared 510(K)
- K141136LEICA FL8002Cleared 510(K)
- K133719PDE-NEO2Cleared 510(K)
- K133993CAAS WORKSTATION2Cleared 510(K)
- K130003XIRALITE FLOURESCENCE IMAGING SYSTEM X42Cleared 510(K)
- K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES2Cleared 510(K)
- K113594C-THV SYSTEM2Cleared 510(K)
- K113034GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM2Cleared 510(K)
- K111209INTEGRATED INNOVA - S5I SYSTEM OPTION2Cleared 510(K)
- K110256THE IC-PRO SYSTEM2Cleared 510(K)
- K100371SPY INTRA-OPERATIVE IMAGING SYSTEM2Cleared 510(K)
- K100849SYNC-RX SYSTEM, MODEL AS000102Cleared 510(K)
- K100468ZEISS INFRARED 800 WITH FLOW 800 OPTION2Cleared 510(K)
- K090745ARTIS ZEE / ZEEGOS WITH SW VC142Cleared 510(K)
- K083745THE IC-PRO SYSTEM, MODEL VERSION 3.22Cleared 510(K)
- K082907IC-PRO SYSTEM, VERSION 3.1.0.42Cleared 510(K)
- K073328CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA2Cleared 510(K)
- K080612LEICA FL8002Cleared 510(K)
- K073290ARTIS ZEE AND ZEEGO2Cleared 510(K)
- K073130SPY FLUORESCENT IMAGING SYSTEM2Cleared 510(K)
- K073088SPY FLUORESCENT IMAGING SYSTEM2Cleared 510(K)
- K071619SPY FLUORESCENT IMAGING SYSTEM2Cleared 510(K)
- K072591CARDIOP-B SYSTEM, VERSION 2.12Cleared 510(K)
- K072222SPY FLUORESCENT IMAGING SYSTEM2Cleared 510(K)
- K072006DAR-9400F2Cleared 510(K)
- K071717GE OEC ALTITUDE2Cleared 510(K)
- K071037SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP20002Cleared 510(K)
- K063345SPY IMAGING SYSTEM2Cleared 510(K)
- K062360BRANSIST SAFIRE2Cleared 510(K)
- K061871LEICA MODEL FL8002Cleared 510(K)
- K060867SPY INTRAOPERATIVE IMAGING SYSTEM2Cleared 510(K)
- K060749XPERCT2Cleared 510(K)
- K052500DAR-8000F2Cleared 510(K)
- K052076DAR-8000I2Cleared 510(K)
- K052039GE OEC ALTITUDE2Cleared 510(K)
- K042961SPY INTRA-OPERATIVE IMAGING SYSTEM: SP20002Cleared 510(K)
- K042646DYNACT2Cleared 510(K)
- K041949ALLURA XPER FD102Cleared 510(K)
- K041027DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D2Cleared 510(K)
- K030139THE CARDIOP-B SYSTEM2Cleared 510(K)
- K032443DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE2Cleared 510(K)
- K033184LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-4002Cleared 510(K)
- K031333PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.22Cleared 510(K)
- K023970QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS2Cleared 510(K)
- K023441PHILIPS MULTIDIAGNOST ELEVA2Cleared 510(K)
- K010721AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM2Cleared 510(K)
- K010391ATLAS MULTI-PURPOSE DSA SYSTEM2Cleared 510(K)
- K002840MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM2Cleared 510(K)
- K993947KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY2Cleared 510(K)
- K993763QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)2Cleared 510(K)
- K993765QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)2Cleared 510(K)
- K991922DIGITAL IMAGING SYSTEM (BSR)2Cleared 510(K)
- K991231HITACHI VERSIFLEX2Cleared 510(K)
- K984545RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS2Cleared 510(K)
- K983877PHILIPS INTEGRIS 3D RA OPTION2Cleared 510(K)
- K982203CAAS II LVA BIPLANE OPTION2Cleared 510(K)
- K974679THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM2Cleared 510(K)
- K974367ADVANTX LCN, ADVANTX LCLP2Cleared 510(K)
- K973270LEG'MAP OPTION2Cleared 510(K)
- K973482PHILIPS INTEGRIS V5000 AND BV50002Cleared 510(K)
- K972655CONTROL SYRINGE2Cleared 510(K)
- K973368STRAIT'MAP OPTION2Cleared 510(K)
- K972229IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM2Cleared 510(K)
- K973342DAR-3000B2Cleared 510(K)
- K971176VIEW ARCHIVING STATION2Cleared 510(K)
- K971181THE MIDVIEW-MEDCON'S DICOM VIEWER2Cleared 510(K)
- K971489RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 42Cleared 510(K)
- K972136TV MONITOR (P12/17)2Cleared 510(K)
- K971365PHILIPS INTEGRIS H50002Cleared 510(K)
- K970738KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT2Cleared 510(K)
- K970525STATNET2Cleared 510(K)
- K955179CONTRAST MEDIA SET2Cleared 510(K)
- K961451DICOMNET2Cleared 510(K)
- K955519ANALYTICAL REVIEW STATION2Cleared 510(K)
- K960575ADVANTX LCV+2Cleared 510(K)
- K954581ARC SERIES2Cleared 510(K)
- K955395DAR-2400-15B/30B2Cleared 510(K)
- K945400HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA1002Cleared 510(K)
- K954309ANGIOREX2Cleared 510(K)
- K953563VANGUARD XR-350 CINEANGIOGRAM PROJECTOR2Cleared 510(K)
- K952704PHILIPS EASYVISION2Cleared 510(K)
- K945540CAAS II2Cleared 510(K)
- K946378BCM 400CP2Cleared 510(K)
- K945449UNICATH LLU ANGIOGRAPHIC SYSTEM2Cleared 510(K)
- K944952ANGIOGRAPHIC SYSTEM2Cleared 510(K)
- K943545CEILING SUSPENDED C-ARM SUPPORT MH-1002Cleared 510(K)
- K945459DLX2Cleared 510(K)
- K945375ADVANTX LCA2Cleared 510(K)
- K945293TOP ACOM STATION2Cleared 510(K)
- K945483COMPAS2Cleared 510(K)
- K943355GEMNET2Cleared 510(K)
- K940172CARDIOVASCULAR MEASUREMENT SYSTEM-CMS2Cleared 510(K)
- K936002CINEMAC QAS2Cleared 510(K)
- K935026DIGITAL MEDIA CONVERTER (D-MC)2Cleared 510(K)
- K941979VIDEO PLUS WITH ANALYTICAL WORKSTATION2Cleared 510(K)
- K942503UNICATH FAMILY2Cleared 510(K)
- K942120ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION2Cleared 510(K)
- K941177ANGIOREX CAS-05A2Cleared 510(K)
- K941946LCA ANGIOGRAPHIC IMAGING SYSTEM2Cleared 510(K)
- K940484COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K933460DVFX, MODEL M2562Cleared 510(K)
- K933664POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)2Cleared 510(K)
- K934496X-RAY ANGIOGRAPHIC SYSTEM2Cleared 510(K)
- K932410HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY2Cleared 510(K)
- K931184MULTI-VIEW PROCESSOR (MVP)2Cleared 510(K)
- K933073HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE2Cleared 510(K)
- K933058HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW2Cleared 510(K)
- K930635MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K931170SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)2Cleared 510(K)
- K926258DLX2Cleared 510(K)
- K925961OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM2Cleared 510(K)
- K926082CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT2Cleared 510(K)
- K924719ANCOR2Cleared 510(K)
- K924708CINENET CARDIAC IMAGE NETWORK2Cleared 510(K)
- K924137CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)2Cleared 510(K)
- K924828BI-N2Cleared 510(K)
- K922222ANGIOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K923654POLY DIAGNOST CDX2Cleared 510(K)
- K923813PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION2Cleared 510(K)
- K920862BCM-400C2Cleared 510(K)
- K923112ANGIO-BAND2Cleared 510(K)
- K922804AWOS ANGIOGRAPHIC WORKSTATION2Cleared 510(K)
- K922622PHILIPS CARDIAC WORKSTATION2Cleared 510(K)
- K921101PHILIPS INTEGRIS V3000 FILM2Cleared 510(K)
- K920705POLYTRON DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K920434ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM2Cleared 510(K)
- K914376DXS DIGITAL X-RAY SUBTRACTION2Cleared 510(K)
- K915199STORZ IMAGING SYSTEM2Cleared 510(K)
- K915232GRUNDIG ELECTRONICS VARIOUS MODELS2Cleared 510(K)
- K914313HICOR2Cleared 510(K)
- K913685UNICATH EP.2Cleared 510(K)
- K911732ADVANCE DISPOSABLE CONTROL SYRINGE2Cleared 510(K)
- K912416ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM2Cleared 510(K)
- K913120POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K905518BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET2Cleared 510(K)
- K910654CINEMEASURE (TM)2Cleared 510(K)
- K910370PHILIPS INTEGRIS V3000 AND V40002Cleared 510(K)
- K905653ADVANTX AFM ANGIO SYSTEM S18082Cleared 510(K)
- K903493NAMIC CONTRAST SAVINGS DELIVERY SYSTEM2Cleared 510(K)
- K903941SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-24002Cleared 510(K)
- K903373CATHETERIZATION C-ARM SUPPORT MH-51C(F)2Cleared 510(K)
- K903372CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A2Cleared 510(K)
- K903371CATHETERIZATION C-ARM SUPPORT MH-51B(F)2Cleared 510(K)
- K904540VIDEO SYSTEM INTERFACE MODELS2Cleared 510(K)
- K904447SONY CINE VIDEO SYSTEM SME-35002Cleared 510(K)
- K903375HICOR2Cleared 510(K)
- K902542PHILIPS INTEGRIS C2000 SYSTEM2Cleared 510(K)
- K897115ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)2Cleared 510(K)
- K896088FEMORAL ANGIOGRAPHY DRAPE2Cleared 510(K)
- K892849UNICATH A2Cleared 510(K)
- K890348LC, CARDIAC POSITIONER #B5078A2Cleared 510(K)
- K890352MULTISKOP2Cleared 510(K)
- K884912ANGIOSTAR2Cleared 510(K)
- K884008SONY CINE VIDEO SYSTEM SME-33002Cleared 510(K)
- K883860ADVANTAGE2Cleared 510(K)
- K883831IMAGER2Cleared 510(K)
- K880690SIEMENS PACS/I-A2Cleared 510(K)
- K882358PULSED FLUOROSCOPIC CONTROL MODEL:PF-022Cleared 510(K)
- K883072DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM2Cleared 510(K)
- K874910SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2002Cleared 510(K)
- K875380SHIMADZU CATHETERIZATION C-ARM STAND MH-102Cleared 510(K)
- K875372SHIMADZU CATHETERIZATION C-ARM STAND ER-2002Cleared 510(K)
- K875373C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-202Cleared 510(K)
- K875374SHIMADZU CEILING-SUSPENDED C-ARM CH-502Cleared 510(K)
- K875375SHIMADZU LATERAL C-ARM MH-302Cleared 510(K)
- K875376SHIMADZU CATHETERIZATION C-ARM STAND MH-50B2Cleared 510(K)
- K875379SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A2Cleared 510(K)
- K875184UNICATH LAB2Cleared 510(K)
- K852331SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC2Cleared 510(K)
- K853044STERICOVER2Cleared 510(K)
- K850455QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM2Cleared 510(K)
- K842494MATRIS INSTRU. VIDEO IMAGER 1010-2Cleared 510(K)
- K842495MATRIX VIDEO IMAGER 1020 COMPACT CAMER2Cleared 510(K)
- K834496ISOREX LS-362Cleared 510(K)
- K813588CTF MODEL 93002Cleared 510(K)
- K812913OMEGA II ANGIOGRAPHIC TABLE2Cleared 510(K)
- K812721DIGITRON2Cleared 510(K)
- K812238D.I.V.A.S.2Cleared 510(K)
- K811149PANDOROS 1200A2Cleared 510(K)
- K810183PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION2Cleared 510(K)
- K781991ANGIOSKIP2Cleared 510(K)
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- 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
HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K933058
- 510(k) Type
- Traditional
- Applicant
- HEARTWARE INTL. CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/28/1993
- Days to Decision
- 98 days
- Submission Type
- Statement