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
- K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)1Cleared 510(K)
- K2125873D-RD-S1Cleared 510(K)
- K163687OLINDA EXM1Cleared 510(K)
- K160933Discovery NM 750b Bopsy1Cleared 510(K)
- K162052Sentinella 102, Sentinella 102 Horus1Cleared 510(K)
- K143156Sentinella 102; Sentinella 102 Horus1Cleared 510(K)
- K123408ERGO IMAGING SYSTEM1Cleared 510(K)
- K111791LUMAGEM MOLECULAR BREAST IMAGING SYSTEM1Cleared 510(K)
- K110384DILON 6800 ACELLA (ACELLA)1Cleared 510(K)
- K110601SENTINELLA 1021Cleared 510(K)
- K102231DISCOVERY NM 750B1Cleared 510(K)
- K101391SCANDIA-45 GAMMA CAMERA SYSTEM1Cleared 510(K)
- K100838ERGO IMAGING SYSTEM1Cleared 510(K)
- K093706PROXISCAN MODEL 1011Cleared 510(K)
- K082588GAMMALOC SYSTEM, MODEL 03-000011Cleared 510(K)
- K092471MODEL SENTINELLA 1021Cleared 510(K)
- K081757VERISTA IMAGING ISOCAM II GAMMA CAMERA1Cleared 510(K)
- K081829CAPIMAGE1Cleared 510(K)
- K073456T-QUEST SYSTEM1Cleared 510(K)
- K071195KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.51Cleared 510(K)
- K062141MAMMOPAD RADIOLUCENT CUSHION1Cleared 510(K)
- K052473CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 00001Cleared 510(K)
- K051402ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM1Cleared 510(K)
- K033960OLINDA/EXM1Cleared 510(K)
- K040587MINI GAMMA CAMERA, MODEL MGC-5001Cleared 510(K)
- K023373ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-5001011Cleared 510(K)
- K022342EZ-SCOPE AN, EZ-SCOPE LIGHT1Cleared 510(K)
- K020643EZ-SCOPE AN & EZ-SCOPE AN LITE1Cleared 510(K)
- K003775PORTABLE BREAST COMPRESSION DEVICE1Cleared 510(K)
- K993813LUMAGEM SCINTILLATION CAMERA1Cleared 510(K)
- K984466DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X51Cleared 510(K)
- K961104NOTEBOOK IMAGER1Cleared 510(K)
- K945792IM512P1Cleared 510(K)
- K943602DI-20001Cleared 510(K)
- K935273VISION FX 40 & 80 SERIES GAMMA CAMERA1Cleared 510(K)
- K932701CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS1Cleared 510(K)
- K934766CARBON FIBER PALLET1Cleared 510(K)
- K932673APEX SPX CARDIAL1Cleared 510(K)
- K933513R &D BATTERIES, INC. PART # 5015, 5192, 54821Cleared 510(K)
- K933256FAN BEAM COLLIMATOR1Cleared 510(K)
- K932957QUANTEM (TM)1Cleared 510(K)
- K923180SPECTURN, MODEL TTK-1281Cleared 510(K)
- K930283THYRUS1Cleared 510(K)
- K926550UNIX-LINK1Cleared 510(K)
- K926083NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES1Cleared 510(K)
- K924639NEW DETECTOR FOR TRANSCAM/POLARIS S3151Cleared 510(K)
- K924878NEW DETECTOR OPTION1Cleared 510(K)
- K923356MEDX ROTATIONAL GANTRY SYSTEM1Cleared 510(K)
- K921296ADAC S3151Cleared 510(K)
- K910967NEUROCAM1Cleared 510(K)
- K905074MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM1Cleared 510(K)
- K911346SOPHYCAMERA DSX BODYTRAK1Cleared 510(K)
- K905412ES/ULTRA DISPLAY AND PROCESSING STATION1Cleared 510(K)
- K903469GAMMA 600 NUCLEAR MEDICINE COMPUTER1Cleared 510(K)
- K905827FULL VIEW OMEGA TABLE1Cleared 510(K)
- K904174STARCAM 40001Cleared 510(K)
- K904050MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA1Cleared 510(K)
- K903030SOPHYCAMERA DSM 3151Cleared 510(K)
- K903988PANORAMIC OMEGA IMAGING TABLE1Cleared 510(K)
- K900773NUCLEAR MAX1Cleared 510(K)
- K900689MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA1Cleared 510(K)
- K894931SOPHYCAMERA DSX RECTANGULAR1Cleared 510(K)
- K893379XENOS MOBILECAM1Cleared 510(K)
- K885054SYSTEM SEVENTY SEVEN1Cleared 510(K)
- K884672APEX 115 NUCLEAR MEDICINE PROCESSOR1Cleared 510(K)
- K884675APEX 609R ANGER CAMERA1Cleared 510(K)
- K884674APEX 415 ANGER CAMERA1Cleared 510(K)
- K884673APEX 215M MOBILE ANGER CAMERA1Cleared 510(K)
- K884661D-SCOPE III1Cleared 510(K)
- K885242MICRODELTA II1Cleared 510(K)
- K880878CX250 MOBILE GAMMA CAMERA & DCS CONSOLE1Cleared 510(K)
- K881013MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A1Cleared 510(K)
- K882312MODEL 3000 NUCLEAR CAMERA1Cleared 510(K)
- K875198DIGITAL NUCLEAR IMAGING SYSTEM1Cleared 510(K)
- K872297DS-7 NUCLEAR MEDICINE GAMMA CAMERA1Cleared 510(K)
- K872127D-SCOPE II AND D-SCOPE IIC1Cleared 510(K)
- K871175JUMBO DIGITAL GAMMACAMERA, GCA-901A1Cleared 510(K)
- K870818BODYSCAN1Cleared 510(K)
- K870703SKAN D-SCOPE1Cleared 510(K)
- K861637WEIGHTED ACQUISITION MODULE1Cleared 510(K)
- K852648STARPORT MODEL H3300AA1Cleared 510(K)
- K853482ACE COMPUTER SYSTEM1Cleared 510(K)
- K853470JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W21Cleared 510(K)
- K852089SATURN NUCLEAR MEDICINE COMPUTER SYSTEM1Cleared 510(K)
- K851644SPECTRUM 150 DT1Cleared 510(K)
- K850463BASICAM COUNTER BALANCE CAMERA1Cleared 510(K)
- K850397ORBITOR II COUNTER BALANCE CAMERA1Cleared 510(K)
- K844218TOMOGRAPHIC GANTRY1Cleared 510(K)
- K843716NUCLEAR 700 MEDICINE MECHANICAL POSIT-1Cleared 510(K)
- K843558DELTANODE, MEGA DELTA, DELTA LINK-1Cleared 510(K)
- K843288KETRONIC MEDAX - N1Cleared 510(K)
- K841964MICRO DELTA & CELTAPRO1Cleared 510(K)
- K841906MAXICAMERA 400 AC1Cleared 510(K)
- K840052DIGITAL PROCESSING SYSTEM1Cleared 510(K)
- K833821INTERAD 5201Cleared 510(K)
- K833811CARDIAC CAMERA1Cleared 510(K)
- K832505IMAGE PROCESSING SYS A31Cleared 510(K)
- K820244ADD'L TERMINAL SUPPORT FOR STAR BASIC1Cleared 510(K)
- K813073OMEGA 500 RECTANGULAR FIELD CAMERA W/SC1Cleared 510(K)
- K811629DYNA- MO1Cleared 510(K)
- K811715ROTA CAMERA1Cleared 510(K)
- K811676MAXI CAMERA/D1Cleared 510(K)
- K811187MEDTRONIC A2 CLINICAL IMAGING SYSTEM1Cleared 510(K)
- K810974GAMMA CAMERA1Cleared 510(K)
- K802475A2 IMAGE PROCESSING SYSTEM1Cleared 510(K)
- K801654MAXI CAMERA 611Cleared 510(K)
- K801653MAXI CAMERA 371Cleared 510(K)
- K801368A2 IMAGE PROCESSING SYSTEM1Cleared 510(K)
- K791682CLEON 720 LARGE FIELD GAMMA CAMERA1Cleared 510(K)
- K790466U-MAT1Cleared 510(K)
- K790499MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER1Cleared 510(K)
- K790463MODU-SET COLLIMOTOR1Cleared 510(K)
- K790081CAMERA, CLEON 720 LARGE FIELD GAMMA1Cleared 510(K)
- K782029MAXI CAMERA 400T1Cleared 510(K)
- K782047PROCESSING SYSTEM, A2 IMAGE1Cleared 510(K)
- K781739CAMERA, GCA-10A, LOW ENERGY1Cleared 510(K)
- K781673MAXI-CAMERA 5351Cleared 510(K)
- K780969GAMMA CAMERA1Cleared 510(K)
- K780971CLINICAL ACQUISITION MODULE1Cleared 510(K)
- K780855GAMMA CAMERA1Cleared 510(K)
- K780491DATA CAMERA1Cleared 510(K)
- K780165PROCESSOR, VIDEO IMAGE VIP-5501Cleared 510(K)
- K780155DUAL CHANNEL PULSE HEIGHT ANALYZER1Cleared 510(K)
- K780060CAMERA, GAMMA1Cleared 510(K)
- K771599GAMMA CAMERAS -GXA-301 & GCA-4021Cleared 510(K)
- K770954UNIVUE I1Cleared 510(K)
- K770753PORTA CAMERA IIC1Cleared 510(K)
- K770531UNICAM I1Cleared 510(K)
- K770343MAXICAMERA II1Cleared 510(K)
- K761159PORTACAMERA 11-B1Cleared 510(K)
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- 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
UNIVUE I
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K770954
- 510(k) Type
- Traditional
- Applicant
- UNION CARBIDE CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/1/1977
- Days to Decision
- 37 days