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
- K251650Insight Enhanced™ DRF (EN-1002-01)2Cleared 510(K)
- K242488Soteria E-View2Cleared 510(K)
- K242948Adora DRFi (04550010)2Cleared 510(K)
- K233380TRIDENT Mobile Fluoroscopy System2Cleared 510(K)
- K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)2Cleared 510(K)
- K232910CombiDiagnost R902Cleared 510(K)
- K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.52Cleared 510(K)
- K220871Nautilus2Cleared 510(K)
- K212890Nyquist.IQ2Cleared 510(K)
- K212837ProxiDiagnost N902Cleared 510(K)
- K212145DR 800 with DSA, DR 8002Cleared 510(K)
- K210469Insight Agile DRF2Cleared 510(K)
- K203428Ziehm Vision RFD2Cleared 510(K)
- K203010Platinum dRF Imaging System2Cleared 510(K)
- K200965XR-MX/10002Cleared 510(K)
- K203087CombiDiagnost R902Cleared 510(K)
- K202235ArtPIX DRF2Cleared 510(K)
- K200396Insight Enhanced DRF Digital Imaging System2Cleared 510(K)
- K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)2Cleared 510(K)
- K191504PowerDR2Cleared 510(K)
- K191877FLUOROspeed2Cleared 510(K)
- K191310Insight Essentials DRF Digital Imaging System2Cleared 510(K)
- K182834CS-series-FP with Optional ROI Accessory CA-100S2Cleared 510(K)
- K190373SonialVision G42Cleared 510(K)
- K173395MECALL CLISIS SYSTEMS, Discovery RF1802Cleared 510(K)
- K180651Uroview FD II2Cleared 510(K)
- K180589DR 800 with MUSICA Dynamic2Cleared 510(K)
- K163210Philips CombiDiagnost R902Cleared 510(K)
- K161019Uroview FD2Cleared 510(K)
- K160301Platinum dRF Imaging System2Cleared 510(K)
- K150306D2RS_AT Digital Dynamic Remote System2Cleared 510(K)
- K151485GENESIS2Cleared 510(K)
- K142341X-RAY TV SYSTEM SONIALVISION G42Cleared 510(K)
- K133434GENESIS II2Cleared 510(K)
- K140380OPERA SWING2Cleared 510(K)
- K141541XIDF-AWS801, ANGIO WORKSTATION, V5.312Cleared 510(K)
- K132289GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM2Cleared 510(K)
- K133553KALARE2Cleared 510(K)
- K131075X-RAY TV SYSTEM SONIAL VISION G42Cleared 510(K)
- K131766PLATINUM DRF IMAGING SYSTEM2Cleared 510(K)
- K132904ZIEHM VISION RFD2Cleared 510(K)
- K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWARE2Cleared 510(K)
- K130318NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)2Cleared 510(K)
- K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS8012Cleared 510(K)
- K122768GENESIS2Cleared 510(K)
- K121293CS-SERIES-FP WITH 3030+OPTION2Cleared 510(K)
- K112054INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V2Cleared 510(K)
- K111292LUMINOS AGILE2Cleared 510(K)
- K110785KALARE DIAGNOSTIC X-RAY TABLE SYSTEM2Cleared 510(K)
- K103038DUET DRF2Cleared 510(K)
- K101491UROSKOP OMNIA2Cleared 510(K)
- K082830INFX-8000H, INFINIX-I2Cleared 510(K)
- K081621INFX-8000C (INFINIX CC-I AND VC-I)2Cleared 510(K)
- K081491SMITH & NEPHEW CDS SYSTEM2Cleared 510(K)
- K081582INFX-8000V, INFINIX-CFI AND INFINIX VFI2Cleared 510(K)
- K081091PRECISION 500D R&F X-RAY SYSTEM2Cleared 510(K)
- K080859DRF 43432Cleared 510(K)
- K070390FLUOROPRO RF DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K061028PRECISION THUNIS 800+2Cleared 510(K)
- K052610IMAGE STAR II2Cleared 510(K)
- K051602AXIOM SIRESKOP SD2Cleared 510(K)
- K051136SMITH & NEPHEW CDS SYSTEM2Cleared 510(K)
- K051025FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM2Cleared 510(K)
- K050866CENTRION 500 C-ARM SYSTEM2Cleared 510(K)
- K050692FLXIS2Cleared 510(K)
- K042698UNFORS PATIENT SKIN DOSIMETER (PSD)2Cleared 510(K)
- K040870SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS2Cleared 510(K)
- K024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM2Cleared 510(K)
- K022911MODEL AMI1200 C-ARM2Cleared 510(K)
- K022899PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.02Cleared 510(K)
- K022565TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-0009152Cleared 510(K)
- K021021MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS2Cleared 510(K)
- K020055PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION2Cleared 510(K)
- K012424SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM2Cleared 510(K)
- K010772ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM2Cleared 510(K)
- K011624EXPEDIO 500D R&F X-RAY SYSTEM2Cleared 510(K)
- K010392ATHENA REMOTE CONTROLLED RF SYSTEM2Cleared 510(K)
- K010187KIMAX, MODEL 10242Cleared 510(K)
- K004037X-RAY SYSTEM XR-MX2Cleared 510(K)
- K000987VFSS IMAGER, MODEL SIS-3002Cleared 510(K)
- K993896MCA-601, C-ARM MOBILE2Cleared 510(K)
- K992603XRT 600 R/F, WRF 06002Cleared 510(K)
- K993038TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)2Cleared 510(K)
- K990055B-400 CEILING MOUNTED POSSITIONER, MODEL B-4002Cleared 510(K)
- K982319CAREGRAPH2Cleared 510(K)
- K982345VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K981414LC POSITIONER2Cleared 510(K)
- K982028FLUOROSPOT COMPACT2Cleared 510(K)
- K981227SYMPHONY 360 REMOTE CONTROL TABLE2Cleared 510(K)
- K974058FS IV MINI C-ARM SYSTEM2Cleared 510(K)
- K973744UNICATH SP BI-PLANE (MODEL M269 & M289)2Cleared 510(K)
- K973067DRTS REMOTE CONTROL DRAPE2Cleared 510(K)
- K973073DRTS IMAGE INTENSIFIER DRAPE2Cleared 510(K)
- K972442CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.0022Cleared 510(K)
- K970947B-350 CEILING MOUNTED C-POSITIONER2Cleared 510(K)
- K970608EVT MARKER BOARD2Cleared 510(K)
- K961782BIO-BINKI2Cleared 510(K)
- K964990HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)2Cleared 510(K)
- K964322VIPOR UNIT2Cleared 510(K)
- K963888C-ARM TABLE IVS-1002Cleared 510(K)
- K963617SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-1202Cleared 510(K)
- K961140FLUOROPLUS CARDIAC TV2Cleared 510(K)
- K953974CAMVISION 10002Cleared 510(K)
- K961207EP-X BIPLANE2Cleared 510(K)
- K962606TOPOGRAPHIC IMAGING MARKER2Cleared 510(K)
- K962140ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.3002Cleared 510(K)
- K961690CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.1052Cleared 510(K)
- K961193FULL FRAME ZOOM SYSTEM2Cleared 510(K)
- K955687RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY2Cleared 510(K)
- K953113SBDX MOBILE FLUOROSCOPY SYSTEM2Cleared 510(K)
- K951261DFI-1000 AND DVS-475 IMAGING DEVICES2Cleared 510(K)
- K960266SIREGRAPH CF2Cleared 510(K)
- K954945HANEL MAVIG MONITOR SUSPENSION SYSTEM2Cleared 510(K)
- K954590MAX-1000A/R12Cleared 510(K)
- K953950FLUORO CATHETER2Cleared 510(K)
- K952493FLUORECORD MODEL 7622Cleared 510(K)
- K952456IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM2Cleared 510(K)
- K950781COMPACT 76002Cleared 510(K)
- K946081FLUOREX DTA-400A2Cleared 510(K)
- K951358SIRESKOP SX2Cleared 510(K)
- K936236SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES2Cleared 510(K)
- K950683ARTHROGRAM TRAY2Cleared 510(K)
- K943156SYSTEM, IMAGE PROCESSING2Cleared 510(K)
- K950971MOBIL C-ARM, REGURBISHED, VARIOUS MODELS2Cleared 510(K)
- K950631ID400 SERIES ARMBOARDS2Cleared 510(K)
- K945460PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION2Cleared 510(K)
- K941917FLUOROPLUA CARDIAC AND/OR INSTAVIEW2Cleared 510(K)
- K942019MODEL FP-1002Cleared 510(K)
- K943272VISUALIZER 20002Cleared 510(K)
- K944973NRF SYSTEM2Cleared 510(K)
- K943532PANORAMIC CORPORATION HDLX2Cleared 510(K)
- K943447V-MAX OPTIONS2Cleared 510(K)
- K943805PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD2Cleared 510(K)
- K940295UROVIEW MODEL 26002Cleared 510(K)
- K942841OEC 9012Cleared 510(K)
- K942674ANGIOREST TABLE PAD SYSTEM2Cleared 510(K)
- K942264DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)2Cleared 510(K)
- K941611TDA-4000/A42Cleared 510(K)
- K926560EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER2Cleared 510(K)
- K933472SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES2Cleared 510(K)
- K936136UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE2Cleared 510(K)
- K933473CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM2Cleared 510(K)
- K933791PHILIPS ANGIOPRO RELEASE 2.12Cleared 510(K)
- K934626GOODALL LASER TARGETING DEVICE2Cleared 510(K)
- K933100ARC-6002Cleared 510(K)
- K934481EP-X2Cleared 510(K)
- K933299QL MULTIPULSE 20482Cleared 510(K)
- K932445SIRESKOP CX2Cleared 510(K)
- K931941SUNSCOPE 1002Cleared 510(K)
- K931268URETERAL COMPRESSION DEVICE2Cleared 510(K)
- K930885PNEUMATIC COMPRESSION DEVICE2Cleared 510(K)
- K926064FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A2Cleared 510(K)
- K926434SIS-300(N)-DIA SCAN2Cleared 510(K)
- K926122FLUOREX2Cleared 510(K)
- K924879EP 30002Cleared 510(K)
- K925251LIXI IMAGING SCOPE. MODIFICATION2Cleared 510(K)
- K923107BODY BAND RESTRAINT STRAP SET2Cleared 510(K)
- K922977EXPOSET2Cleared 510(K)
- K924164DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT2Cleared 510(K)
- K923585DIGITAL FLUORO STORE2Cleared 510(K)
- K922274MEDRAD PATHFINDER-E ROADMAPPING SYSTEM2Cleared 510(K)
- K923454SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES2Cleared 510(K)
- K923453SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES2Cleared 510(K)
- K923137CSL X-RAY IMAGESCOPE2Cleared 510(K)
- K922240ELECTRONIC PHOTOSPOT 202Cleared 510(K)
- K920746VFC UNIT2Cleared 510(K)
- K922012SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES2Cleared 510(K)
- K922013SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES2Cleared 510(K)
- K922011SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES2Cleared 510(K)
- K920720DIGITAL RADIOGRAPHY SYSTEM IDR-10002Cleared 510(K)
- K920721DIGITAL RADIOGRAPHY SYSTEM IDR-20002Cleared 510(K)
- K920550DISPLAY PROCESSOR - MODEL IDP51002Cleared 510(K)
- K915405P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)2Cleared 510(K)
- K914414VIDEO FLUOROSCOPE2Cleared 510(K)
- K913886SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER2Cleared 510(K)
- K915592PEGASUS LATERAL CARDIAC POSITIONER2Cleared 510(K)
- K914446UROVIEW 2000, MODIFICATION2Cleared 510(K)
- K905694FVP-1000 FAMILY AND FVP-1000D FAMILY2Cleared 510(K)
- K914525FLUROSPOT H VERSION 22Cleared 510(K)
- K913012DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES2Cleared 510(K)
- K912896DIGISTORE 21002Cleared 510(K)
- K912341MULTICAM I 8X102Cleared 510(K)
- K912470PHILIPS DIAGNOST 962Cleared 510(K)
- K912380LASER BEAM LOCALIZER FOR SIREMOBIL 42Cleared 510(K)
- K911454FC20002Cleared 510(K)
- K910384VIDEO ANNOTATOR MODEL PK23102Cleared 510(K)
- K905278STS(TM) FLUOROSCOPIC IMAGING MODULE2Cleared 510(K)
- K905111DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES2Cleared 510(K)
- K904986PROGRAMMABLE VIDEO CONTROLLER MODEL PK20602Cleared 510(K)
- K904012PHILIPS INTEGRIS I 2000 SYSTEM2Cleared 510(K)
- K902982G.E. POLARIX II C-ARM2Cleared 510(K)
- K903821PSC-1 W/OTHER NUMERICAL2Cleared 510(K)
- K902981G.E. FLUOROCON 300 IMAGING SYSTEM2Cleared 510(K)
- K902983SIEMEN'S SIREMOBILE II C-ARM2Cleared 510(K)
- K902980G.E. XT CEILING TUBE SUSPENSION2Cleared 510(K)
- K902583JOINT MOTON IMAGER(TM)2Cleared 510(K)
- K902005MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE2Cleared 510(K)
- K901671HAFCON (FLOURO FOOTSWITCH)2Cleared 510(K)
- K902927DIGITAL PHOTOSPOT2Cleared 510(K)
- K902535SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM2Cleared 510(K)
- K901405DIGIFORMER HR DFP-50A2Cleared 510(K)
- K901323HYDRA VIEW IMAGING SYSTEM2Cleared 510(K)
- K901153SONY VO-5800H VIDEOCASSETTE RECORDER2Cleared 510(K)
- K900893CARDIOVUE CFS-1002Cleared 510(K)
- K896331V2465P X-RAY IMAGE INTENSIFIER2Cleared 510(K)
- K895546MODIFIED SPANTRON FRAME FREEZE2Cleared 510(K)
- K895394MOBILE X-RAY TELEVISION UNIT WHA-10A/B2Cleared 510(K)
- K895730X-RAY EQUIPMENT (VARIOUS TYPES)2Cleared 510(K)
- K894913DA-100HS2Cleared 510(K)
- K893475UROVIEW II2Cleared 510(K)
- K893644PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER2Cleared 510(K)
- K893476ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.2Cleared 510(K)
- K893131DIGITAL SPOT IMAGING (DSI)2Cleared 510(K)
- K884598SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-12002Cleared 510(K)
- K884028MULTI CAMERA CONTROL UNIT (MCCU)2Cleared 510(K)
- K890878PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD2Cleared 510(K)
- K890745SC-1000 WITH SUFFIXES (SCAN CONVERTER)2Cleared 510(K)
- K884578POLARIX 2 AND POLARIX 2E2Cleared 510(K)
- K883580UNIVERSAL ABC CONTROLER2Cleared 510(K)
- K884317MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM2Cleared 510(K)
- K883372ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT2Cleared 510(K)
- K883985CARDIAC CX2Cleared 510(K)
- K883161HIMOBILIX 2N2Cleared 510(K)
- K882311SHIMADZU LATERAL C-ARM MH-312Cleared 510(K)
- K882175HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP2Cleared 510(K)
- K882176VTR-122Cleared 510(K)
- K880527CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM2Cleared 510(K)
- K874905P2020 MOBILE C-ARM IMAGE INTENSIFIER2Cleared 510(K)
- K874901REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE2Cleared 510(K)
- K875157SHIMADZU CATHETERIZATION C-ARM STAND MH-50A2Cleared 510(K)
- K873985FLUORO COVER2Cleared 510(K)
- K872061LP LATERAL FLUORO POSITIONER (B5077A)2Cleared 510(K)
- K871743VIDEO PLUS MODELS VP500, VP500A AND VP10002Cleared 510(K)
- K871911THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION2Cleared 510(K)
- K871127DTV-4112 FLUOROSCOPIC TELEVISION CAMERA2Cleared 510(K)
- K870869DTV-411OP2Cleared 510(K)
- K871119CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D2Cleared 510(K)
- K863853EAZY COVERS2Cleared 510(K)
- K870429EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186)2Cleared 510(K)
- K864749TELAMAT2Cleared 510(K)
- K864837MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM2Cleared 510(K)
- K864584FLUOROVISION CONTRAST ENHANCER2Cleared 510(K)
- K862120SCX SYSTEM2Cleared 510(K)
- K861785FLUOROSCOPE BAND BAG2Cleared 510(K)
- K854953DIAMED MODELS 600, 900, 960, 9642Cleared 510(K)
- K852346XISCAN MODEL 10002Cleared 510(K)
- K855213PET-SCOPE II IMAGE INTENSIFIER2Cleared 510(K)
- K853984CANON X-RAY IMAGE DISTRIBUTOR2Cleared 510(K)
- K851031EXPOSCOP MOBILE IMAGING SYSTEM2Cleared 510(K)
- K850959EQUIPMENT SNAP KOVERS2Cleared 510(K)
- K844375EIGEN FLORO-STOR FS-1002Cleared 510(K)
- K843920FLUOROSCAN/TM BY HEALTHMATE2Cleared 510(K)
- K843972ANGIOPLUS-S2Cleared 510(K)
- K843917FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL2Cleared 510(K)
- K843235STENOSCOP2Cleared 510(K)
- K842217IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS2Cleared 510(K)
- K842191DIGISTORE 502Cleared 510(K)
- K840621FLUOROSCOPIC IMAGE INTENSIFIER2Cleared 510(K)
- K840225C-ARM CEILING CRANE FT-22Cleared 510(K)
- K840364REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY2Cleared 510(K)
- K840191DIGITAL FLUOROGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K840134CAMTEX 10002Cleared 510(K)
- K840390TECHNICARE MODEL 10472Cleared 510(K)
- K834287DIGITAL RADIOGRAPHY SYS-DPS71002Cleared 510(K)
- K834286BI-PLANE DIGITAL FLUOROGRAPHY DFX70002Cleared 510(K)
- K833641IMAGE INTENSIFIER TUBE W/HOUSING &2Cleared 510(K)
- K833531CT SCANNING ACCESSORIES2Cleared 510(K)
- K833237DIGITAL RADIOGRAPHY SYS DUAL GANTRIES2Cleared 510(K)
- K833530DIGITAL FLUOROGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K833230REGISTREX 1000 DIGITAL RADIOGRAPHY SYS2Cleared 510(K)
- K827489HYPERLUX 30 IMAGE SYSTEM2Cleared 510(K)
- K820178PI808 MOBILE C-ARM IMAGE INTENSIFIER2Cleared 510(K)
- K820184LATERAL ANGULATING FLUORO SUSPENSION2Cleared 510(K)
- K813158RDP-20002Cleared 510(K)
- K813217DIGITAL FLUROGRAPHIC IMAGING SYSTEM2Cleared 510(K)
- K812963IBIS II2Cleared 510(K)
- K812775FLUORICON L300 IMAGE INTENSIFIER2Cleared 510(K)
- K812561LATERAL ANGULATING FLUORO SUSPENSION SYS2Cleared 510(K)
- K812217FLUORO AUTOMATIC BRIGHTNESS SYS2Cleared 510(K)
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- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
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- 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
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- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2Product Code
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- 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
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- 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
Insight Enhanced DRF Digital Imaging System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K200396
- 510(k) Type
- Special
- Applicant
- Imaging Engineering, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/6/2020
- Days to Decision
- 17 days
- Submission Type
- Summary