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
- K252570EzSensor HD, EzSensor UHD2Cleared 510(K)
- K250687Cocoon Solo (DX-7020s)2Cleared 510(K)
- K251206Digital X-Ray DentiMax Pro Imaging System2Cleared 510(K)
- K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)2Cleared 510(K)
- K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)2Cleared 510(K)
- K241649DUO1 and DUO22Cleared 510(K)
- K232325RAYSCAN a-Expert2Cleared 510(K)
- K231660Digital image scanner of dental2Cleared 510(K)
- K233053DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor2Cleared 510(K)
- K232552TuxDeluxe (Size 1 6100B, Size 2 6101B)2Cleared 510(K)
- K230998Digital Wireless Intraoral X-Ray Sensor2Cleared 510(K)
- K230916WeSensor2Cleared 510(K)
- K232255EZSensor XHD2Cleared 510(K)
- K232158GenX-CR2Cleared 510(K)
- K231202QuickRayPRO2Cleared 510(K)
- K230811Digital Intraoral X-Ray Sensor2Cleared 510(K)
- K230732Eagle S/Saevo Slim/D700 Slim2Cleared 510(K)
- K230095ScanX Swift 2.0, ScanX Swift View 2.02Cleared 510(K)
- K221955Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM202Cleared 510(K)
- K221008HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)2Cleared 510(K)
- K220423PAPAYA & PAPAYA Plus2Cleared 510(K)
- K220556OpenSensorX Series2Cleared 510(K)
- K220422Dental sensors NanoPix1, NanoPix22Cleared 510(K)
- K214091Dental Image Plate Scanner, Model DFC-4T-SMART2Cleared 510(K)
- K220277Digital Intraoral X-ray Sensor2Cleared 510(K)
- K213637JAZZ Solo sensor2Cleared 510(K)
- K212279Digital Intraoral X-ray Imaging System2Cleared 510(K)
- K212080Imaging Plate Scanner, i-Scan2Cleared 510(K)
- K202369RXS 10002Cleared 510(K)
- K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-22Cleared 510(K)
- K211317CRUXVIEW2Cleared 510(K)
- K211688DC-Air and Athlos-1 and Athlos-Air2Cleared 510(K)
- K210312PlutoX Digital Intraoral X-Ray Imaging System2Cleared 510(K)
- K203116SensorX2Cleared 510(K)
- K203374X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)2Cleared 510(K)
- K202664Clio Prime and Clio Pedo2Cleared 510(K)
- K202633ScanX Edge2Cleared 510(K)
- K200625I-View Gold and Imagen Gold Dental Sensors2Cleared 510(K)
- K200284R-Sensor, R-Sensor2Cleared 510(K)
- K191719X-MIND Trium2Cleared 510(K)
- K192766Digital Intraoral Imaging Plate System2Cleared 510(K)
- K191623ScanX Touch/ScanX Duo Touch2Cleared 510(K)
- K190234ODI HD Dental Sensor2Cleared 510(K)
- K183637Cruxcan (CRX-1000)2Cleared 510(K)
- K182198Panoura X-ERA PF/NF/MF2Cleared 510(K)
- K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)2Cleared 510(K)
- K181636Aurora2Cleared 510(K)
- K181358Televere Digital Dental Imaging System2Cleared 510(K)
- K173646FS Ergo2Cleared 510(K)
- K172918DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)2Cleared 510(K)
- K173046Cocoon Portable Handheld X-Ray System2Cleared 510(K)
- K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)2Cleared 510(K)
- K170733ScanX Intraoral View2Cleared 510(K)
- K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight2Cleared 510(K)
- K163175Bel-Cypher Pro2Cleared 510(K)
- K163224JAZZ SOLO Sensor2Cleared 510(K)
- K163282Apex Dental Sensors2Cleared 510(K)
- K162619I View and Imagen Sensor2Cleared 510(K)
- K162585SuniIQ Digital Radiography System2Cleared 510(K)
- K161131FONA Pan/Ceph2Cleared 510(K)
- K160788RIOScan (RPS500)2Cleared 510(K)
- K160386ReadeR, VieweR, QuickScan PSP2Cleared 510(K)
- K153144TIO-H DIGITAL RADIOGRAPHY SENSOR2Cleared 510(K)
- K152162Myray- HYPERION X52Cleared 510(K)
- K151926QuickRay HD Intraoral Sensor2Cleared 510(K)
- K153060Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S2Cleared 510(K)
- K150823EDLENi Intra-Oral Sensor2Cleared 510(K)
- K151087CS 8100SC, CS8100SC Access2Cleared 510(K)
- K142995SOPIX2Cleared 510(K)
- K151053PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner2Cleared 510(K)
- K151707EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i2Cleared 510(K)
- K150797Digital Dental Intra Oral Sensor, EzSensor Smart2Cleared 510(K)
- K142058RAYSCAN A-EXPERT2Cleared 510(K)
- K143703NICAL SMART MICRO CR system for intraoral dental images2Cleared 510(K)
- K143753Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio2Cleared 510(K)
- K141700PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2Cleared 510(K)
- K140013SOPIX INSIDE, SOPIX2 INSIDE2Cleared 510(K)
- K141130ENCOMPASS2Cleared 510(K)
- K133206Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM2Cleared 510(K)
- K134055ADX4000W2Cleared 510(K)
- K133271OPTEO, VIDEOGRAPH HD2Cleared 510(K)
- K133007DX3000-L2Cleared 510(K)
- K133231DIGORA OPTIME2Cleared 510(K)
- K130419PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2Cleared 510(K)
- K131693RAYSCAN A-EXPERT2Cleared 510(K)
- K131442FIRECR DENTALIMAGING SYSTEM2Cleared 510(K)
- K130088PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM2Cleared 510(K)
- K130585PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2Cleared 510(K)
- K122918RAYSCAN A-EXPERT2Cleared 510(K)
- K122806IMAGE WORKS PANOURA2Cleared 510(K)
- K121800POINT 500 HD POINT500C HD2Cleared 510(K)
- K122643VANTAGE MODEL V5000, V5100, V5000C, V5100C2Cleared 510(K)
- K123419EVA SELECT DIGITAL DENTAL IMAGING SYSTEM2Cleared 510(K)
- K122155PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2Cleared 510(K)
- K120263VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2Cleared 510(K)
- K120975CS 8100 CS 8100 ACCESS2Cleared 510(K)
- K120106APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM2Cleared 510(K)
- K113672PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2Cleared 510(K)
- K120318VIVI ERGON-X HF2Cleared 510(K)
- K113497HYPERION2Cleared 510(K)
- K111103DIGITAL X-RAY IMAGING SYSTEM2Cleared 510(K)
- K102456INTRAORAL BELSENSOR GOLD2Cleared 510(K)
- K112380CLEARVISION2Cleared 510(K)
- K111649CS 76002Cleared 510(K)
- K103290EDLEN IMAGING - GEMINI DUSB2Cleared 510(K)
- K111152ROTOGRAPH EVO 3D2Cleared 510(K)
- K111231PANOURA 18S2Cleared 510(K)
- K110768COMPUTED DENTAL RADIOGRAPHY2Cleared 510(K)
- K110371ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY2Cleared 510(K)
- K103689PLANMECA PROMAX 3D MID2Cleared 510(K)
- K110160BEL-CYPHER N2Cleared 510(K)
- K102124DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K100960WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS2Cleared 510(K)
- K093683ORTHOPANTOMOGRAPH OP3002Cleared 510(K)
- K101661MYRAY HYPERION2Cleared 510(K)
- K092329SOPIX 22Cleared 510(K)
- K093590PLANMECA PROMAX 3D MAX2Cleared 510(K)
- K093478KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM2Cleared 510(K)
- K092171VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM2Cleared 510(K)
- K100317DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO2Cleared 510(K)
- K090526MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR2Cleared 510(K)
- K092591ORTHOPANTOMOGRAPH OP302Cleared 510(K)
- K092547DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX2Cleared 510(K)
- K092537DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E95402Cleared 510(K)
- K091866PROGENY VANTAGE PANORAMIC X-RAY SYSTEM2Cleared 510(K)
- K083057I-MAX TOUCH2Cleared 510(K)
- K090458DEXIS SENSOR2Cleared 510(K)
- K090020BEL-CYPHER, MODEL Y9772Cleared 510(K)
- K083532ADX4000-L, DX3000-L2Cleared 510(K)
- K082972KODAK 95002Cleared 510(K)
- K081088MYRAY SKYVIEW2Cleared 510(K)
- K081925SNAPSHOT2Cleared 510(K)
- K081903XIOS PLUS WALL-MODULE2Cleared 510(K)
- K080889KODAK 9000C EXTRAORAL IMAGING SYSTEM2Cleared 510(K)
- K073696VERAVIEWEPOCS2Cleared 510(K)
- K073365DENTAL DIGITAL X-RAY IMAGING SYSTEM2Cleared 510(K)
- K073435KODAK 9000, KODAK 9000 3D2Cleared 510(K)
- K073350SCANORA 3D2Cleared 510(K)
- K072134SCHICK COMPUTED ORAL RADIOLOGY SYSTEM2Cleared 510(K)
- K072244PLANMECA PROONE2Cleared 510(K)
- K072357NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K070811CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX40002Cleared 510(K)
- K063837SIGMA M2Cleared 510(K)
- K070664PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).2Cleared 510(K)
- K070535RETROPAN CCD-TWAIN-USB2Cleared 510(K)
- K070505KRYSTAL-X WIFI2Cleared 510(K)
- K070304DIGORA PCT/DIGIPOD2Cleared 510(K)
- K070219SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM2Cleared 510(K)
- K063459CRANEX NOVUS2Cleared 510(K)
- K062403IMAX CEPH DIGITAL X-RAY SENSOR2Cleared 510(K)
- K062529BELMAX CM MODEL X1682Cleared 510(K)
- K061284I-CAT SCANNER2Cleared 510(K)
- K053172UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)2Cleared 510(K)
- K061114WDS, SIZE 2 AND SIZE 22Cleared 510(K)
- K060892GALILEOS2Cleared 510(K)
- K060328PLANMECA PROMAX 3D2Cleared 510(K)
- K060178VIX WIN PRO2Cleared 510(K)
- K053558CEPH, MODEL 49002Cleared 510(K)
- K060179BIO-RAY SDX DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM2Cleared 510(K)
- K060149SUNIPAN IMAGING SYSTEM & ACCESSORIES2Cleared 510(K)
- K053221CDMX-H2Cleared 510(K)
- K053220VERAVIEW IC 5, MODEL XDP12Cleared 510(K)
- K051664SCAN300FP / RETROPAN (VDC)2Cleared 510(K)
- K050693ACCENT2Cleared 510(K)
- K041834ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM2Cleared 510(K)
- K042736CDX DIGITAL X-RAY IMAGING SYSTEM2Cleared 510(K)
- K042372HDS INTRA-ORAL IMAGING SYSTEM2Cleared 510(K)
- K041120EV APAN DIGITAL, MODEL K1VSM20002Cleared 510(K)
- K041831PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR2Cleared 510(K)
- K041580IMAGERAYI2Cleared 510(K)
- K041050DIGORA OPTIME (OR DIGORA ONTIME)2Cleared 510(K)
- K024186X-VIEW2Cleared 510(K)
- K033147CLEARTOOTH DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K033248HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM2Cleared 510(K)
- K031801PANTOS, MODELS: PANTOS 16, AND PANTOS DG2Cleared 510(K)
- K031291CDR PANX, MODEL 47922Cleared 510(K)
- K023346TROPHYPAN2Cleared 510(K)
- K023292APEX HRI DIGITAL RADIOGRAPHY SYSTEM2Cleared 510(K)
- K022953MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM2Cleared 510(K)
- K021718INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY2Cleared 510(K)
- K021542ADC DENTAL2Cleared 510(K)
- K020588X-IMAGE DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K013893SCANX2Cleared 510(K)
- K012514DIGIPAN / DPI2Cleared 510(K)
- K013271DXS DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K013659MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM2Cleared 510(K)
- K013650ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD2Cleared 510(K)
- K012170DIGORA PCT2Cleared 510(K)
- K010915CDMX2Cleared 510(K)
- K002425MEDIADENT HDX/MMD HDX SP XRAY SENSOR2Cleared 510(K)
- K001928SIGMA2Cleared 510(K)
- K001439ORTHOCEPH OC100 D2Cleared 510(K)
- K000454DIMEX 22Cleared 510(K)
- K992392RTLX2Cleared 510(K)
- K993958IDX-60 INTRAORAL X-RAY2Cleared 510(K)
- K992385ORTHOPANTOMOGRAPH OP100D2Cleared 510(K)
- K992644SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM2Cleared 510(K)
- K990087DMD DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K990528ORTHOPHOS 3/3 CEPH/3 DS2Cleared 510(K)
- K990002QUICKRAY DSX 7302Cleared 510(K)
- K990049CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 20002Cleared 510(K)
- K983267DIGORA FOR WINDOWS 2.02Cleared 510(K)
- K983283SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM2Cleared 510(K)
- K983057ORTHOPHOS 5/PLUS/CD2Cleared 510(K)
- 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
- 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
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K221008
- 510(k) Type
- Traditional
- Applicant
- Shanghai Handy Medical Equipment Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/22/2022
- Days to Decision
- 78 days
- Submission Type
- Statement