Anesthesiology
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- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EAGCephalometer2Product Code
- EAHCone, Radiographic, Lead-Lined1Product Code
- EAPUnit, X-Ray, Intraoral2Product Code
- EHBCollimator, X-Ray1Product Code
- EHDUnit, X-Ray, Extraoral With Timer2Product Code
- MUHSystem, X-Ray, Extraoral Source, Digital2Product Code
- EAMScreen, Intensifying, Radiographic1Product Code
- EGTController, Temperature, Radiographic2Product Code
- EGWDryer, Film, Radiographic2Product Code
- EGYProcessor, Radiographic-Film, Automatic, Dental2Product Code
- HBKChair, Pneumoencephalographic2Product Code
- ITXTransducer, Ultrasonic, Diagnostic2Product Code
- ITYAssembly, Tube Housing, X-Ray, Diagnostic1Product Code
- IWNCassette, Measurement, Ardran-Crooks1Product Code
- IWYHolder, Head, Radiographic1Product Code
- IWZFilm, Radiographic1Product Code
- IXACassette, Radiographic Film2Product Code
- IXCIlluminator, Radiographic-Film1Product Code
- IXDSource, Calibration, Sealed, Nuclear1Product Code
- IXFTest-Pattern, Radiographic1Product Code
- IXGPhantom, Anthropomorphic, Radiographic1Product Code
- IXHCamera, Focal Spot, Radiographic1Product Code
- IXJGrid, Radiographic1Product Code
- IXKSystem, Imaging, X-Ray, Electrostatic2Product Code
- IXLDevice, Spot-Film2Product Code
- IXOSynchronizer, Ecg / Respirator, Radiographic1Product Code
- IXQTable, Radiographic, Stationary Top2Product Code
- IXRTable, Radiographic, Tilting2Product Code
- IXWProcessor, Radiographic-Film, Automatic2Product Code
- IXXProcessor, Cine Film2Product Code
- IXYHolder, Radiographic Cassette, Wall-Mounted1Product Code
- IYBTube Mount, X-Ray, Diagnostic1Product Code
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2Product Code
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- 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
- K233539MAMMOMAT B.brilliant2Cleared 510(K)
- K220073RMF-20002Cleared 510(K)
- K211720Planmed Clarity 2D, Planmed Clarify S2Cleared 510(K)
- K212873Aspire Cristalle2Cleared 510(K)
- K210151Digimamo D2Cleared 510(K)
- K202822Helianthus2Cleared 510(K)
- K211725Senographe Pristina2Cleared 510(K)
- K211215SenoBright HD2Cleared 510(K)
- K2029022430MCA with Xmaru W2Cleared 510(K)
- K192317Planmed Clarity 2D and Clarity S2Cleared 510(K)
- K200424Giotto Class (Models - 3000X-YY and 4000X-YY)2Cleared 510(K)
- K193166MAMMOMAT Revelation2Cleared 510(K)
- K193334Pristina Serena Bright2Cleared 510(K)
- K190809Sample Imaging for Senographe Pristina2Cleared 510(K)
- K182951Pristina Serena 3D2Cleared 510(K)
- K173576Pristina Serena2Cleared 510(K)
- K173408Mammomat Revelation2Cleared 510(K)
- K163328Planmed Clarity2Cleared 510(K)
- K172404SenoBright HD2Cleared 510(K)
- K173132ASPIRE Cristalle2Cleared 510(K)
- K172027Adani MammoScan2Cleared 510(K)
- K163302Senographe Pristina2Cleared 510(K)
- K170930RSM 2430C2Cleared 510(K)
- K162670RSM 1824C with RConsole12Cleared 510(K)
- K163252Mammomat Fusion with Stereotactic Biopsy2Cleared 510(K)
- K162268Senographe Pristina2Cleared 510(K)
- K151645MAMMOMAT Fusion2Cleared 510(K)
- K133972ASPIRE CRISTALLE2Cleared 510(K)
- K130704MICRODOSE SI2Cleared 510(K)
- K131885SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)2Cleared 510(K)
- K123520MAMMOMAT INSPIRATION PRIME2Cleared 510(K)
- K122510ICRCO 3600M2Cleared 510(K)
- K122286MAMMOMAL INSPIRATION2Cleared 510(K)
- K123995MICRODOSE SI2Cleared 510(K)
- K123873CONTRAST ENHANCED DIGITAL MAMMOGRAPHY2Cleared 510(K)
- K121963PLANMED NUANCE DIGIGUIDE2Cleared 510(K)
- K121674ASPIRE HD PLUS, ASPIRE HD-S2Cleared 510(K)
- K120246KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)2Cleared 510(K)
- K120255PHILIPS MICRODOSE2Cleared 510(K)
- K110717KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM2Cleared 510(K)
- K111324CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER2Cleared 510(K)
- K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIAL2Cleared 510(K)
- K111646ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR2Cleared 510(K)
- K111434GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L2Cleared 510(K)
- K103485SENOGRAPH DS, SENOGRAPH ESSENSTIAL2Cleared 510(K)
- K111361PLANMED NUANCE EXCEL2Cleared 510(K)
- K110572MAMMODIAGNOST DR2Cleared 510(K)
- K110729ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM2Cleared 510(K)
- K110025SECTRA MICRODOSE MAMMOGRAPHY2Cleared 510(K)
- P080018KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE2PMA Approval
- P010025HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P030010SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P080018KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY2PMA Approval
- P030010SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM2PMA Approval
- P010025HOLOGIC SELENIA DIMENSIONS 2D FULL DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P050014FULL FIELD DIGITAL MAMMOGRAPHY2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P030010MAMMOMAT NOVATION DR2PMA Approval
- P010025SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P050014FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE2PMA Approval
- P010025SELENIA DIMENSIONS (2D) FFDM SYSTEM2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL2PMA Approval
- P010025HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS2PMA Approval
- P990066SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS2PMA Approval
- P990066SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS2PMA Approval
- P990066SENOGRAPHE ESSENTIAL SYSTEM2PMA Approval
- P050014FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)2PMA Approval
- P990066SENOGRAPHE DS FFDM SYSTEM2PMA Approval
- P990066SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P030010SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM2PMA Approval
- P010017FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE DS & 2000D FFDM SYSTEM2PMA Approval
- P030010SIEMENS MAMMOMAT NOVATION FFDM SYSTEM2PMA Approval
- P990066SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P030010SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010017SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P030010SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010017SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010025SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE2PMA Approval
- P010025SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM2PMA Approval
- P010025LORAD DIGITAL BREAST IMAGER2PMA Approval
- P990066GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066MOBILE SENOGRAPHE 2000D2PMA Approval
- P990066SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P010017SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- P990066GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM2PMA Approval
- 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
Pristina Serena 3D
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K182951
- 510(k) Type
- Traditional
- Applicant
- GE Healthcare
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/18/2019
- Days to Decision
- 87 days
- Submission Type
- Summary