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
- 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
- K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)2Cleared 510(K)
- K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.52Cleared 510(K)
- K240465O-arm O2 Imaging System2Cleared 510(K)
- K233230See Factor CT3™2Cleared 510(K)
- K240224Zenition 902Cleared 510(K)
- K240199IntraOp Alignment System2Cleared 510(K)
- K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl2Cleared 510(K)
- K233748CIARTIC Move (VB10)2Cleared 510(K)
- K232420Zenition 302Cleared 510(K)
- K240099Ziehm Vision RFD2Cleared 510(K)
- K240020Ziehm Vision FD2Cleared 510(K)
- K234109Ziehm Solo FD2Cleared 510(K)
- K231700Ziehm Vision FD2Cleared 510(K)
- K230949ARTIS pheno (VE30A)2Cleared 510(K)
- K230950ARTIS icono (VE30A)2Cleared 510(K)
- K231669Ziehm Solo FD2Cleared 510(K)
- K231692Ziehm Vision RFD2Cleared 510(K)
- K233200XPLUS 35 Series (XPLUS 35, XPLUS 35FD)2Cleared 510(K)
- K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR2Cleared 510(K)
- K230871EXTRON 5; EXTRON 72Cleared 510(K)
- K230787Oscar 15 & Oscar 15i2Cleared 510(K)
- K231701Ziehm Vision RFD 3D2Cleared 510(K)
- K222998F32Cleared 510(K)
- K230185ANT-X System2Cleared 510(K)
- K221344nView s1 with nav option2Cleared 510(K)
- K223410Cios Select (VA21) Flat Panel2Cleared 510(K)
- K223409Cios Select (VA21) Image Intensifier2Cleared 510(K)
- K213768Bolt Navigation System2Cleared 510(K)
- K221281Multitom Rax2Cleared 510(K)
- K222070EndoNaut2Cleared 510(K)
- K222080Garion Image-Intensified Fluoroscopic X-Ray System, Mobile2Cleared 510(K)
- K222625Shield System2Cleared 510(K)
- K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.32Cleared 510(K)
- K221922Trinias2Cleared 510(K)
- K221230TRON2Cleared 510(K)
- K221516ARTIS icono (Ceiling Configuration)2Cleared 510(K)
- K220432ARTIS icono (VE21) System2Cleared 510(K)
- K220409ARTIS pheno (VE21) System2Cleared 510(K)
- K221335D²RS and D²RS 90902Cleared 510(K)
- K220311Cardiovascular Angiography System2Cleared 510(K)
- K220946SURGIVISIO Device2Cleared 510(K)
- K212159Shield System2Cleared 510(K)
- K220627SURGIVISIO Device2Cleared 510(K)
- K211780ZEN-2090 Turbo2Cleared 510(K)
- K212212Multitom Rax with True2scale Body Scan Option2Cleared 510(K)
- K213479D²RS and D²RS 90902Cleared 510(K)
- K212442Cydar EV (Series B) and Cydar EV Maps2Cleared 510(K)
- K213455ControlRad Select Model Z2Cleared 510(K)
- K212336Soteria.AI2Cleared 510(K)
- K212956FDR Cross (DR-XD 3000)2Cleared 510(K)
- K212523VFSS Pro Mobile Digital Imaging System2Cleared 510(K)
- K211064nView s1 with nav option2Cleared 510(K)
- K212813Zenition 702Cleared 510(K)
- K212557Virtual C DRF-NEO Digital Imaging System2Cleared 510(K)
- K212383EndoNaut2Cleared 510(K)
- K211777ARCO FP-S2Cleared 510(K)
- K210912Excelsius3D2Cleared 510(K)
- K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 92Cleared 510(K)
- K211191Virtual C DRF Digital Imaging System2Cleared 510(K)
- K203535Trinias2Cleared 510(K)
- K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.22Cleared 510(K)
- K203623StentBoost Mobile2Cleared 510(K)
- K202547Surgivisio system2Cleared 510(K)
- K210309Cios Select (VA21) Flat Panel2Cleared 510(K)
- K210307Cios Select (VA21) Image Intensifier2Cleared 510(K)
- K201743ClarifEye R1.0, ClarifEye Needle2Cleared 510(K)
- K201583SmartCT R1.02Cleared 510(K)
- K210055Cios Alpha2Cleared 510(K)
- K210054Cios Spin2Cleared 510(K)
- K202431ControlRad Select Model Z2Cleared 510(K)
- K203504Cios Flow2Cleared 510(K)
- K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X2Cleared 510(K)
- K203551Alphenix, INFX-8000V/B, /S, V9.12Cleared 510(K)
- K202360Ziehm Vision RFD 3D2Cleared 510(K)
- K200218Digiscan FDX2Cleared 510(K)
- K201156ARTIS pheno (VE2)2Cleared 510(K)
- K200663ControlRad Trace Model 92Cleared 510(K)
- K201172CFP-3131, CFP-22222Cleared 510(K)
- K200917Azurion R2.12Cleared 510(K)
- K200074O-arm O2 Imaging System2Cleared 510(K)
- K193326ARTIS Icono2Cleared 510(K)
- K200887AS-102Cleared 510(K)
- K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System2Cleared 510(K)
- K200360TrackX2Cleared 510(K)
- K192182C0152Cleared 510(K)
- K193230Ziehm Vision FD2Cleared 510(K)
- K183144uMC 560i2Cleared 510(K)
- K190497Ziehm 80002Cleared 510(K)
- K190768ARTIS icono2Cleared 510(K)
- K191503MobileRay Pulse SE Digital Imaging System2Cleared 510(K)
- K182086ARCO FP2Cleared 510(K)
- K190064nView system 12Cleared 510(K)
- K183109ControlRad Trace Model 82Cleared 510(K)
- K190626SyncVision System2Cleared 510(K)
- K183101Zenition 502Cleared 510(K)
- K183040Zenition 702Cleared 510(K)
- K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR2Cleared 510(K)
- K181550Cios Spin2Cleared 510(K)
- K181560Cios Alpha2Cleared 510(K)
- K182546Alphenix, INFX-8000H/B, V8.02Cleared 510(K)
- K182415Alphenix, INFX-8000F/B, V8.02Cleared 510(K)
- K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.02Cleared 510(K)
- K181966SmartPerfusion2Cleared 510(K)
- K181943OSCAR (OSCAR Prime, OSCAR Classic)2Cleared 510(K)
- K181767Cios Select2Cleared 510(K)
- K181407Artis zee/zeego & Artis Q/Q.zen2Cleared 510(K)
- K181830Azurion R2.02Cleared 510(K)
- K181804Alphenix, INFX-8000C/B, V8.02Cleared 510(K)
- K181670Alphenix, INFX-8000V/B, V8.02Cleared 510(K)
- K181834Ultimax-i, DREX-UI80 (V1.60)2Cleared 510(K)
- K173631Intelli-C2Cleared 510(K)
- K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax2Cleared 510(K)
- K180473ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR2Cleared 510(K)
- K173736TrackX2Cleared 510(K)
- K172180OSCAR 152Cleared 510(K)
- K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System2Cleared 510(K)
- K173433ProxiDiagnost N902Cleared 510(K)
- K173664Medtronic O-arm O2 Imaging System2Cleared 510(K)
- K172863Infinix-i, INFX-8000V, V7.02Cleared 510(K)
- K172822Azurion series R1.22Cleared 510(K)
- K173314LessRay System2Cleared 510(K)
- K172700OEC One2Cleared 510(K)
- K172646XIDF-AWS801, Angio Workstation, V7.02Cleared 510(K)
- K172307Dynamic Coronary Roadmap 2.02Cleared 510(K)
- K172574SyncVision System2Cleared 510(K)
- K171829EndoNaut2Cleared 510(K)
- K170800NuVasive LessRay with Enhanced Tracking2Cleared 510(K)
- K171565OEC Elite2Cleared 510(K)
- K170832Ultimax-i, DREX-UI80 V1.602Cleared 510(K)
- K170909Infinix INFX-8000V, V6.402Cleared 510(K)
- K170144StentBoost Live2Cleared 510(K)
- K170130Dynamic Coronary Roadmap2Cleared 510(K)
- K163140SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System2Cleared 510(K)
- K171194AS-10, CXDI-401RF2Cleared 510(K)
- K170752OEC Elite2Cleared 510(K)
- K163286ARTIS pheno2Cleared 510(K)
- K163715Allura Xper R92Cleared 510(K)
- K162859Allura Xper FD series and Allura Xper OR Table series2Cleared 510(K)
- K162148Allura Xper R92Cleared 510(K)
- K162614Infinix, INFX-8000V, V6.352Cleared 510(K)
- K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray System2Cleared 510(K)
- K161976Ziehm Solo FD2Cleared 510(K)
- K161756SyncVision System2Cleared 510(K)
- K160455AneurysmFlow2Cleared 510(K)
- K160147CT TrueView2Cleared 510(K)
- K1618392D Quantitative Analysis2Cleared 510(K)
- K161563Allura Xper FD series and Allura Xper OR Table series2Cleared 510(K)
- K160088Cydar EV2Cleared 510(K)
- K153244Cios Fusion2Cleared 510(K)
- K153232Cios Select2Cleared 510(K)
- K152697INFX-8000C, V6.202Cleared 510(K)
- K153147Cios Connect2Cleared 510(K)
- K152696INFX-8000V, V6.202Cleared 510(K)
- K152785XIDF-AWS801, Angio Workstation, V6.202Cleared 510(K)
- K152928Multitom Rax2Cleared 510(K)
- K151598VesselNavigator Rel. 1.02Cleared 510(K)
- K151000O-Arm O2 Imaging System2Cleared 510(K)
- K151904SyncVision System2Cleared 510(K)
- K150967XIDF-AWS801, Angio Workstation, V6.102Cleared 510(K)
- K142740Ziehm Vision RFD 3D2Cleared 510(K)
- K142736XIDF-AWS801, Angio Workstation, v5.312Cleared 510(K)
- K142273EmboGuide2Cleared 510(K)
- K143281Ultimax-i2Cleared 510(K)
- K143225INFX-8000V with Wireless Footswitch2Cleared 510(K)
- K142126EP NAVIGATOR REL. 5.02Cleared 510(K)
- K140041ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM2Cleared 510(K)
- K142243LessRay with Tracking2Cleared 510(K)
- K142708VERADIUS UNITY2Cleared 510(K)
- K141574ARTIS ZEE/ZEEGO SW VC212Cleared 510(K)
- K141979ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES2Cleared 510(K)
- K133535INFX-8000V, V5.302Cleared 510(K)
- K133819VERADIUS2Cleared 510(K)
- K140138HEARTNAVIGATOR RELEASE 2.02Cleared 510(K)
- K132027OEC 9800 PLUS2Cleared 510(K)
- K133580ARTIS ONE2Cleared 510(K)
- K133278DISCOVERY IGS 7402Cleared 510(K)
- K132094CIOS ALPHA2Cleared 510(K)
- K133292ALLURA XPER FD; OR TABLE2Cleared 510(K)
- K123508TRINIAS2Cleared 510(K)
- K1321472D PERFUSION2Cleared 510(K)
- K132558SYNC-RX SYSTEM2Cleared 510(K)
- K132970LESSRAY2Cleared 510(K)
- K132305STENTBOOST REL. 42Cleared 510(K)
- K130893XPERCT REL. 32Cleared 510(K)
- K131263XPERGUIDE2Cleared 510(K)
- K130638ALLURACLARITY XPER FD SERIES X-RAY SYSTEM2Cleared 510(K)
- K122644ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC212Cleared 510(K)
- K121772ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 12Cleared 510(K)
- K123529ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM2Cleared 510(K)
- K122457GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS2Cleared 510(K)
- K120282CARDNAV2Cleared 510(K)
- K123226LESSRAY2Cleared 510(K)
- K122234OEC 9900 ELITE2Cleared 510(K)
- K121444FLAT PANEL DETECTOR2Cleared 510(K)
- K113403GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM2Cleared 510(K)
- K120073INFX-8000V WITH2Cleared 510(K)
- K113027SYNGO AORTIC VALVEGUIDE SOFTWARE2Cleared 510(K)
- K111551OEC(R) 9800, OEC(R) 9800 PLUS2Cleared 510(K)
- K112180I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)2Cleared 510(K)
- K111344I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)2Cleared 510(K)
- K103425ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM2Cleared 510(K)
- K103416NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM2Cleared 510(K)
- K102529D2RF DIGITAL DYNAMIC REMOTE SYSTEM2Cleared 510(K)
- K101868INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V2Cleared 510(K)
- K100102CS-SERIES-FP2Cleared 510(K)
- K102005ALLURA XPER OR TABLE SERIES2Cleared 510(K)
- K101833INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I52Cleared 510(K)
- K093066I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I52Cleared 510(K)
- K093688CANON, MODEL URS-50RF2Cleared 510(K)
- K092438ZIEHM SOLO2Cleared 510(K)
- K092439CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF2Cleared 510(K)
- K091918ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO2Cleared 510(K)
- K092004GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ2Cleared 510(K)
- K091658GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 21212Cleared 510(K)
- K083545ZIEHM VISION RFD2Cleared 510(K)
- K082781OEC 9900 ELITE2Cleared 510(K)
- K090590VERADIUS, MODEL 718-1302Cleared 510(K)
- K083725RADPRO ION2Cleared 510(K)
- K081073HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F2Cleared 510(K)
- K082243PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS2Cleared 510(K)
- K080847RFVISION, MODEL 9.9D2Cleared 510(K)
- K073543OEC 9900 ELITE2Cleared 510(K)
- K062623AXIOM LUMINOS DRF2Cleared 510(K)
- K070834CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)2Cleared 510(K)
- K070123TCA 5R / 5S2Cleared 510(K)
- K062647E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-502Cleared 510(K)
- K0619539900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS2Cleared 510(K)
- K061534ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM2Cleared 510(K)
- K061203ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM2Cleared 510(K)
- K061173CPIVISION DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K061163INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT2Cleared 510(K)
- K052202AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM2Cleared 510(K)
- K060259DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 21212Cleared 510(K)
- K053279UROVANTAGE2Cleared 510(K)
- K052884MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR2Cleared 510(K)
- K052412INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ2Cleared 510(K)
- K051064ZIEHM QUANTUM2Cleared 510(K)
- K050489INNOVA 21002Cleared 510(K)
- K043076GE OEC FLUOROSTAR2Cleared 510(K)
- K042793ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)2Cleared 510(K)
- K042053INNOVA 4100, INNOVA 31002Cleared 510(K)
- K041931OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION2Cleared 510(K)
- K041932OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM2Cleared 510(K)
- K041780NEW BRID2Cleared 510(K)
- K041605PRECISION RXI ANALOG X-RAY SYSTEM2Cleared 510(K)
- K040675AXIOM ARTIS U2Cleared 510(K)
- K032761KMC-950 C-ARM MOBILE SYSTEM2Cleared 510(K)
- K033737ALLURA XPER FD202Cleared 510(K)
- K033486GE PRECISION MPI2Cleared 510(K)
- K033244DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION2Cleared 510(K)
- K031637INNOVA 31002Cleared 510(K)
- K032046PHILLIPS OMNIDIAGNOST ELEVA2Cleared 510(K)
- K030544RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K030061PS 3000 DIGATAL PHOTOSPOT SYSTEM2Cleared 510(K)
- K024200INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)2Cleared 510(K)
- K023178INNOVA 41002Cleared 510(K)
- K022322INNOVA AND INNOVA 2000 S2Cleared 510(K)
- K022114IMPERIUM2Cleared 510(K)
- K022069OEC FLUOROTRAK 9800 PLUS2Cleared 510(K)
- K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM2Cleared 510(K)
- K012490ORION DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K013608DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D2Cleared 510(K)
- K011311UROLOGIC2Cleared 510(K)
- K011292ZIEHM VISION2Cleared 510(K)
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- K010435PHILIPS BV PULSERA/ENDURA2Cleared 510(K)
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- K002016PHILIPS INTEGRIS ALLURA2Cleared 510(K)
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- 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
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K163140
- 510(k) Type
- Traditional
- Applicant
- GEMSS MEDICAL SYSTEMS CO., LTD
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/26/2017
- Days to Decision
- 198 days
- Submission Type
- Summary