Anesthesiology
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- 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
- 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
- K243705Saige-Density (2.5.0)2Cleared 510(K)
- K242270OrthoNext Platform System2Cleared 510(K)
- K240793MSKai2Cleared 510(K)
- K242461IRISeg2Cleared 510(K)
- K241543DrAid™ for Liver Segmentation2Cleared 510(K)
- K240680CDM Insights2Cleared 510(K)
- K240645Sonix Health2Cleared 510(K)
- K242203BriefCase-Quantification2Cleared 510(K)
- K242359Strain AI (SAI001)2Cleared 510(K)
- K241312TeraRecon Cardiac.Chambers.MR (1.0.0)2Cleared 510(K)
- K241108RemedyLogic AI MRI Lumbar Spine Reader2Cleared 510(K)
- K243189TumorSight Viz2Cleared 510(K)
- K242215Neurophet AQUA (V3.1)2Cleared 510(K)
- K242781cvi42 Software Application2Cleared 510(K)
- K241430EchoMeasure2Cleared 510(K)
- K240786AutoChamber2Cleared 510(K)
- K240553LVivo Software Application2Cleared 510(K)
- K241561MammoScreen BD2Cleared 510(K)
- K240943LungVision2Cleared 510(K)
- K240036PIUR tUS Infinity2Cleared 510(K)
- K241280Constellation (CON-001)2Cleared 510(K)
- K240094LumiNE US; Lumi2Cleared 510(K)
- K241681Overjet Image Enhancement Assist2Cleared 510(K)
- K240791ADAS 3D2Cleared 510(K)
- K240411uAI Portal2Cleared 510(K)
- K242300MI View&GO2Cleared 510(K)
- K242275syngo.via MI Workflows; Scenium; syngo MBF2Cleared 510(K)
- K241847Imbio PHA (4.0.0)2Cleared 510(K)
- K241684Overjet Charting Assist2Cleared 510(K)
- K241098NeuroQuant2Cleared 510(K)
- K240740qCT LN Quant2Cleared 510(K)
- K241211CoLumbo2Cleared 510(K)
- K242054OptimMRI (v2)2Cleared 510(K)
- K233822i2Contour2Cleared 510(K)
- K240953AI Platform 2.0 (AIP002)2Cleared 510(K)
- K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)2Cleared 510(K)
- K233457RUS2Cleared 510(K)
- K241329SubtleSYNTH (1.x)2Cleared 510(K)
- K240736SMART Bun-Yo-Matic X-Ray2Cleared 510(K)
- K240582VEA Align; spineEOS2Cleared 510(K)
- K233196Medihub Prostate2Cleared 510(K)
- K240642SMART Bun-Yo-Matic CT2Cleared 510(K)
- K241083SIS System2Cleared 510(K)
- K233925Relu Creator2Cleared 510(K)
- K241038Cardiac CT Function Software Application2Cleared 510(K)
- K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)2Cleared 510(K)
- K240769LVivo IQS2Cleared 510(K)
- K233209uOmnispace.CT2Cleared 510(K)
- K241112BriefCase-Quantification2Cleared 510(K)
- K232331InVision Precision LVEF (LVEF)2Cleared 510(K)
- K233186uOmnispace.MR2Cleared 510(K)
- K240172Preview Shoulder2Cleared 510(K)
- K233676Us2.v22Cleared 510(K)
- K233211AVIEW CAC2Cleared 510(K)
- K233030BoneMRI2Cleared 510(K)
- K231690iCAS-LV2Cleared 510(K)
- K231683inHEART Models2Cleared 510(K)
- K232613CT Cardiomegaly2Cleared 510(K)
- K233590Overjet Charting Assist2Cleared 510(K)
- K232363Viz HDS, Viz Volume Plus, Viz ICH+2Cleared 510(K)
- K232698NemoScan2Cleared 510(K)
- K233512Rapid (6.0)2Cleared 510(K)
- K231324DASI Dimensions (V1.0)2Cleared 510(K)
- K231917VEA Align2Cleared 510(K)
- K231130TumorSight Viz2Cleared 510(K)
- K231929iQ-solutions2Cleared 510(K)
- K232231QP-Brain®2Cleared 510(K)
- K232096Transpara Density 1.0.02Cleared 510(K)
- K233568Ceevra Reveal 3+2Cleared 510(K)
- K232440Adravision Perio2Cleared 510(K)
- K232856Syngo Carbon Clinicals2Cleared 510(K)
- K232000syngo.via MI Workflows; Scenium; syngo MBF2Cleared 510(K)
- K232501AI Platform (AIP001)2Cleared 510(K)
- K232841Axial3D Insight2Cleared 510(K)
- K232257Clarius Bladder AI2Cleared 510(K)
- K232083BriefCase-Quantification2Cleared 510(K)
- K230534BriefCase-Quantification2Cleared 510(K)
- K231955aprevo® Digital Segmentation2Cleared 510(K)
- K232305AI-Rad Companion Brain MR2Cleared 510(K)
- K230209Sonix Health2Cleared 510(K)
- K232367cmAngio® V1.02Cleared 510(K)
- K231398VUNO Med-DeepBrain2Cleared 510(K)
- K230045HipCheck2Cleared 510(K)
- K231149qXR-CTR2Cleared 510(K)
- K223621DeepXray2Cleared 510(K)
- K230913ANDI2Cleared 510(K)
- K230150OptimMRI2Cleared 510(K)
- K230039uOmnispace2Cleared 510(K)
- K231757Ez3D-i /E32Cleared 510(K)
- K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)2Cleared 510(K)
- K231668Spine CAMP™ (1.1)2Cleared 510(K)
- K222745Axial3D Insight2Cleared 510(K)
- K230497Bladder AI (AIBV01)2Cleared 510(K)
- K223646IB Lab LAMA2Cleared 510(K)
- K223556DeepCatch2Cleared 510(K)
- K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACA2Cleared 510(K)
- K230977SIS System2Cleared 510(K)
- K222676Ceevra Reveal 32Cleared 510(K)
- K223501ViewFinder Software Version 1.12Cleared 510(K)
- K213986CerebralGo Plus2Cleared 510(K)
- K213272Formus Hip2Cleared 510(K)
- K222174RadioLens v1.02Cleared 510(K)
- K222036MPXA-20002Cleared 510(K)
- K230197BoneMRI v1.62Cleared 510(K)
- K223296Videa Perio Assist2Cleared 510(K)
- K223396Rapid RV/LV2Cleared 510(K)
- K222970LVivo IQS2Cleared 510(K)
- K222406Clarius AI2Cleared 510(K)
- K214036AVIEW2Cleared 510(K)
- K223268BrainInsight2Cleared 510(K)
- K222275Saige-Density2Cleared 510(K)
- K223032SIS System (Version 5.6.0)2Cleared 510(K)
- K221762BoneMRI v1.42Cleared 510(K)
- K222428Syngo Dynamics (Version VA40F)2Cleared 510(K)
- K221632Spine CAMP™2Cleared 510(K)
- K211611QIR Suite2Cleared 510(K)
- K221738NS-HGlio2Cleared 510(K)
- K221100Viz RV/LV2Cleared 510(K)
- K222172MI View&GO2Cleared 510(K)
- K213645ClearPoint Maestro Brain Model2Cleared 510(K)
- K221432Customize2Cleared 510(K)
- K213998cvi42 Auto Imaging Software Application2Cleared 510(K)
- K220940EchoPAC Software Only, EchoPAC Plug-in2Cleared 510(K)
- K220956Libby Echo:Prio2Cleared 510(K)
- K220815BrainInsight2Cleared 510(K)
- K220497CoLumbo2Cleared 510(K)
- K213706AI-Rad Companion Brain MR2Cleared 510(K)
- K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System2Cleared 510(K)
- K213779Customize2Cleared 510(K)
- K203744Arterys MICA2Cleared 510(K)
- K212012Follicle Clarity2Cleared 510(K)
- K210747Caption Interpretation Automated Ejection Fraction Software2Cleared 510(K)
- K213544TOMTEC-ARENA2Cleared 510(K)
- K202404BoneMRI2Cleared 510(K)
- K212690qXR-BT2Cleared 510(K)
- K213275EchoGo Core (2.0)2Cleared 510(K)
- K212466LVivo Seamless2Cleared 510(K)
- K210831OnQ Neuro2Cleared 510(K)
- K211161Critical Care Suite with Endotracheal Tube Positing AI algorithm2Cleared 510(K)
- K203785ClariSIGMAM2Cleared 510(K)
- K203555AmCAD-UT2Cleared 510(K)
- K211431breastscape v1.02Cleared 510(K)
- K211222qER-Quant2Cleared 510(K)
- K210791Us2.v12Cleared 510(K)
- K210719Change Healthcare Anatomical AI2Cleared 510(K)
- K211506PowerLook Density Assessment V4.02Cleared 510(K)
- K211459syngo.via MI WorkFlows, Scenium, syngo MBF2Cleared 510(K)
- K203502MEDO-Thyroid2Cleared 510(K)
- K210556Preview Shoulder2Cleared 510(K)
- K203256Imbio RV/LV Software2Cleared 510(K)
- K210053LVivo Software Application2Cleared 510(K)
- K201411Visage Breast Density2Cleared 510(K)
- K201195syngo.via MI Workflows, syngo MBF2Cleared 510(K)
- K202013WRDensity by Whiterabbit.ai2Cleared 510(K)
- K202546LVivo Seamless2Cleared 510(K)
- K193283AI-Rad Companion Prostate MR2Cleared 510(K)
- K200621Caption Interpretation Automated Ejection Fraction Software2Cleared 510(K)
- K192969Ezra Plexo Software2Cleared 510(K)
- K200232LVivo Software Application2Cleared 510(K)
- K200356MEDO ARIA2Cleared 510(K)
- K200974QLAB Advanced Quantification Software2Cleared 510(K)
- K192601uWS-MR2Cleared 510(K)
- K192437Arterys MICA2Cleared 510(K)
- K191647QLAB Advanced Quantification Software2Cleared 510(K)
- K191171EchoGo Core2Cleared 510(K)
- 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
BrainInsight
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K220815
- 510(k) Type
- Traditional
- Applicant
- Hyperfine, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/19/2022
- Days to Decision
- 120 days
- Submission Type
- Summary