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
- K251167uDR Aurora CX2Cleared 510(K)
- K250788Definium Tempo Select2Cleared 510(K)
- K250790INNOVISION-DXII2Cleared 510(K)
- K250738YSIO X.pree2Cleared 510(K)
- K242019GXR-Series Diagnostic X-Ray System2Cleared 510(K)
- K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))2Cleared 510(K)
- K242119INNOVISION-EXII2Cleared 510(K)
- K241068uDR 780i2Cleared 510(K)
- K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);2Cleared 510(K)
- K242678Definium Pace Select ET2Cleared 510(K)
- K242478GF85 (models GF85-3P, GF85-SP)2Cleared 510(K)
- K233920EOSedge2Cleared 510(K)
- K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)2Cleared 510(K)
- K233662Radiography 7300 C2Cleared 510(K)
- K233543YSIO X.pree2Cleared 510(K)
- K233719FDR Visionary Suite2Cleared 510(K)
- K233381DRX-Evolution Plus System2Cleared 510(K)
- K233722RADspeed Pro2Cleared 510(K)
- K233532MULTIX Impact E2Cleared 510(K)
- K230800XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF502Cleared 510(K)
- K231761PodSKAN HF Diagnostic X-ray System2Cleared 510(K)
- K231995AcuityUDR2Cleared 510(K)
- K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)2Cleared 510(K)
- K231892Definium Pace Select2Cleared 510(K)
- K223550DMX2Cleared 510(K)
- K230241Jumong General2Cleared 510(K)
- K223842DRX - Compass2Cleared 510(K)
- K223060DigiX FDX2Cleared 510(K)
- K221853OTC DDR2Cleared 510(K)
- K220919MULTIX Impact E2Cleared 510(K)
- K220271Hand Diagnostic Radiography Imaging System2Cleared 510(K)
- K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)2Cleared 510(K)
- K220518SKANRAD 4002Cleared 510(K)
- K213057ExamVue Duo2Cleared 510(K)
- K214012Straight Arm DDR2Cleared 510(K)
- K213700MULTIX Impact, MULTIX Impact C2Cleared 510(K)
- K212186Philips Radiology Smart Assistant2Cleared 510(K)
- K210692DigitalDiagnost2Cleared 510(K)
- K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems2Cleared 510(K)
- K203345MULTIX Impact2Cleared 510(K)
- K203340MULTIX Impact C2Cleared 510(K)
- K202388Apolo D / Apolo S2Cleared 510(K)
- K201825MiniCAT 2D2Cleared 510(K)
- K201670YSIO X.pree2Cleared 510(K)
- K202293Radiographic System Challenge X2Cleared 510(K)
- K202572GXR-Series Diagnostic X-Ray System2Cleared 510(K)
- K202394EOSedge2Cleared 510(K)
- K202156DIAMOND-5A/6A/8A2Cleared 510(K)
- K201725DigitalDiagnost C502Cleared 510(K)
- K201640DuraDiagnost2Cleared 510(K)
- K201373DRX-Compass2Cleared 510(K)
- K200944UNIEXPERT 2 PLUS2Cleared 510(K)
- K193089MULTIX Impact2Cleared 510(K)
- K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System2Cleared 510(K)
- K193574Q-Rad System2Cleared 510(K)
- K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography2Cleared 510(K)
- K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard2Cleared 510(K)
- K191879DRX-Evolution with Carestream Digital Tomosynthesis2Cleared 510(K)
- K192079EOSedge2Cleared 510(K)
- K190330DRX-Evolution/Plus with Dual Energy2Cleared 510(K)
- K192541DigiX FDX2Cleared 510(K)
- K192453DIAMOND-5A/6A/8A2Cleared 510(K)
- K192364GXR-Series Diagnostic X-Ray System2Cleared 510(K)
- K192293uDR 592h, uDR 596i2Cleared 510(K)
- K191699Discovery XR656 HD with VolumeRad2Cleared 510(K)
- K191418Multix Fusion Max2Cleared 510(K)
- K190601MasteRad MX302Cleared 510(K)
- K183541ProRad 2FC and ProRad 3NC Stationary Radiographic Systems2Cleared 510(K)
- K182517MULTIX Impact2Cleared 510(K)
- K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A2Cleared 510(K)
- K182134ARiX RAD Radiographic System2Cleared 510(K)
- K182880Halifax Imaging Kit2Cleared 510(K)
- K182647GC702Cleared 510(K)
- K182622GU60A, GU60A-652Cleared 510(K)
- K181629GC85A2Cleared 510(K)
- K181413uDR 592h, uDR 596i2Cleared 510(K)
- K181279Ysio Max2Cleared 510(K)
- K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM852Cleared 510(K)
- K180663LaVid FMTS DIAGNOSTIC X-RAY SYSTEM2Cleared 510(K)
- K180765Televere Podiatry X-Ray System HF2Cleared 510(K)
- K173517RADspeed fit2Cleared 510(K)
- K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System2Cleared 510(K)
- K173953uDR 780i2Cleared 510(K)
- K173828GU60A & GU60A-652Cleared 510(K)
- K173612Optima XR646 HD2Cleared 510(K)
- K172229GC85A2Cleared 510(K)
- K172869Discovery XR656 HD2Cleared 510(K)
- K162529DigiX FDX2Cleared 510(K)
- K160857HF 718BD X-Ray System2Cleared 510(K)
- K163410DigitalDiagnost C502Cleared 510(K)
- K163203Carestream DRX-Evolution2Cleared 510(K)
- K163115GC702Cleared 510(K)
- K152813FS-500DDR Medical Radiographic X-Ray System2Cleared 510(K)
- K162971Multix Fusion Max2Cleared 510(K)
- K161937CuattroDR2Cleared 510(K)
- K162224ArtPix Mobile EZ2GO2Cleared 510(K)
- K152294FDR Visionary Suite2Cleared 510(K)
- K160997GC85A2Cleared 510(K)
- K152244RADspeed Pro2Cleared 510(K)
- K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)2Cleared 510(K)
- K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,2Cleared 510(K)
- K152767OTC12D AUTO RADIOGRAPHIC SYSTEM2Cleared 510(K)
- K152788EOS System2Cleared 510(K)
- K151924Q-Rad Radiographic System with Auto-Tracker Option2Cleared 510(K)
- K151219Models 2200DR and 1600DR Digital Stationary Radiographic Systems2Cleared 510(K)
- K151685GUA60A, GU60A-652Cleared 510(K)
- K151419GF50A2Cleared 510(K)
- K150725Visaris Avanse2Cleared 510(K)
- K150816Jumong Series2Cleared 510(K)
- K150663Diagnostic X-ray System2Cleared 510(K)
- K142930Exam Vue DR2Cleared 510(K)
- K150506ELIAN Digital Diagnostic X-ray System2Cleared 510(K)
- K150165GC85A2Cleared 510(K)
- K141837DRX-EVOLUTION2Cleared 510(K)
- K143270Optima XR6462Cleared 510(K)
- K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System2Cleared 510(K)
- K143029Digital Diagnostic X-ray System (GC80)2Cleared 510(K)
- K142773EOS System2Cleared 510(K)
- K133959PODIATRY X-RAY SYSTEM2Cleared 510(K)
- K142049MULTIX FUSION VA30 & VA402Cleared 510(K)
- K133496X TWIN SYSTEM2Cleared 510(K)
- K133695TITAN 112Cleared 510(K)
- K141381DURADIAGNOST2Cleared 510(K)
- K1406830180 INTUITION, 0072 PRECISION2Cleared 510(K)
- K140326XGEO GF502Cleared 510(K)
- K140332XGEO GU60A2Cleared 510(K)
- K140334XGEO GC802Cleared 510(K)
- K132934MULTIX SELECT DR2Cleared 510(K)
- K133259YSIO MAX2Cleared 510(K)
- K132294GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS2Cleared 510(K)
- K123106DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A2Cleared 510(K)
- K123105XGEO GU602Cleared 510(K)
- K122726CPI RAD VISION2Cleared 510(K)
- K123098XGEO GC802Cleared 510(K)
- K122454FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION2Cleared 510(K)
- K122589DFP4343C72Cleared 510(K)
- K122119DX-D FULL LEG FULL SPINE2Cleared 510(K)
- K121854SYSTEM, X-RAY, STATIONARY2Cleared 510(K)
- K121513MULTIX FUSION2Cleared 510(K)
- K120752AERODR STITCHING SYSTEM2Cleared 510(K)
- K121345SR SUITE 1.02Cleared 510(K)
- K121109AERODR X702Cleared 510(K)
- K120034RADIOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K113855PANORAD, PANORAD SL2Cleared 510(K)
- K113248AERODR SYSTEM WITH P-212Cleared 510(K)
- K111655FLAATZ 7602Cleared 510(K)
- K112670DX-D 6002Cleared 510(K)
- K110828DDRELEMENT2Cleared 510(K)
- K103448BRIVO XR3852Cleared 510(K)
- K101779CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K110849PRESTODR 41432Cleared 510(K)
- K102123VIZION DR2Cleared 510(K)
- K102284KRYSTALRAD 560 (FLAATZ 560)2Cleared 510(K)
- K102285KRYSTALRAD (ATAL8)2Cleared 510(K)
- K102408DIGITAL DIAGNOSTIC X-RAY SYSTEM2Cleared 510(K)
- K102349AERODR SYSTEM2Cleared 510(K)
- K103050DX-D 3002Cleared 510(K)
- K101686FDR IMAGE STITCHING OPTION2Cleared 510(K)
- K101042BLADEVIEW2Cleared 510(K)
- K102680Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM2Cleared 510(K)
- K093816DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 16002Cleared 510(K)
- K101435IMIX PANORAD AND SOMARAD2Cleared 510(K)
- K092830DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-10002Cleared 510(K)
- K091752VIZTEK WL2Cleared 510(K)
- K092307IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR2Cleared 510(K)
- K091889DRX-EVOLUTION, MODEL VX3733-SYS2Cleared 510(K)
- K091747FLAATZ 5002Cleared 510(K)
- K083640DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D2Cleared 510(K)
- K090279SEDECAL, MILLENNIUM PLUS2Cleared 510(K)
- K090238SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS2Cleared 510(K)
- K083503DRAD30003/RADREX-I2Cleared 510(K)
- K083510KUBTEC XPERT 202Cleared 510(K)
- K083109SUINSA DIAGNOSTIC X-RAY SYSTEM2Cleared 510(K)
- K083181QV-9000 UNIVERSAL SYSTEM2Cleared 510(K)
- K082604VIZTEK DR, MODELS: DR1000, DR3000, DR40002Cleared 510(K)
- K082261DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS2Cleared 510(K)
- K082798DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 30002Cleared 510(K)
- K082064RADVISION ET DIAGNOSTIC X-RAY SYSTEM2Cleared 510(K)
- K081722YSIO2Cleared 510(K)
- K081836CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM2Cleared 510(K)
- K080614DR VISION NEO, DR VISION DOU2Cleared 510(K)
- K080582MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA2Cleared 510(K)
- K080655CHRYSALIS2Cleared 510(K)
- K080553DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-162Cleared 510(K)
- K073650FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 3712Cleared 510(K)
- K073114IMIX INSIGHT X-RAY SYSTEMS2Cleared 510(K)
- K073632INTUITION, MODEL 01702Cleared 510(K)
- K072867IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K2Cleared 510(K)
- K072659RAD VISION, MODELS E AND EU2Cleared 510(K)
- K071546EOS2Cleared 510(K)
- K072010QUANTUM DIREX SYSTEM2Cleared 510(K)
- K071392PXS-810, PODIATRY X-RAY SYSTEM2Cleared 510(K)
- K071401X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM2Cleared 510(K)
- K071430SYNERAD OMNI, MODELS AN6255 AND AN62652Cleared 510(K)
- K071408X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR2Cleared 510(K)
- K071403X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM2Cleared 510(K)
- K071409X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM2Cleared 510(K)
- K071402X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM2Cleared 510(K)
- K070678DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST2Cleared 510(K)
- K063247XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND2Cleared 510(K)
- K063246XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND2Cleared 510(K)
- K062634ORTHOXP2Cleared 510(K)
- K062417XPLORER 11002Cleared 510(K)
- K062335SEDECAL X PLUS LP PLUS2Cleared 510(K)
- K062405XPLORER 15902Cleared 510(K)
- K061595XAMINER2Cleared 510(K)
- K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 65513862Cleared 510(K)
- K052943DDRFORMULA AND DDRFORMULA PLUS2Cleared 510(K)
- K052541MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM2Cleared 510(K)
- K051967REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS2Cleared 510(K)
- K051258KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 87913452Cleared 510(K)
- K050704MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING2Cleared 510(K)
- K033577UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS2Cleared 510(K)
- K050151MULTIDIAGNOST ELEVA2Cleared 510(K)
- K043025SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN62502Cleared 510(K)
- K042876URS LP DIGITAL, MILLENNIUM, RADPRO2Cleared 510(K)
- K040995SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN61502Cleared 510(K)
- K033345AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS2Cleared 510(K)
- K031535PHILIPS EASYDIAGNOST ELEVA2Cleared 510(K)
- K023008UNIVERSAL SYSTEM, MODEL QV-8002Cleared 510(K)
- K022737HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC2Cleared 510(K)
- K022667HCMI X-RAY2Cleared 510(K)
- K013826AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)2Cleared 510(K)
- K013481DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION2Cleared 510(K)
- K012546OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM2Cleared 510(K)
- K012165OLDELFT THORASCAN MODEL NUMBER 180T2Cleared 510(K)
- K012389REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM2Cleared 510(K)
- K011486Q-RAD RADIOGRAPHIC SYSTEM2Cleared 510(K)
- K011111MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)2Cleared 510(K)
- K001336DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K001341DR5000 DEDICATED CHEST X-RAY SYSTEM2Cleared 510(K)
- K001201MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS2Cleared 510(K)
- K993962PENSIL TRAUMA, MODEL WWS61002Cleared 510(K)
- K993665LEGEND CRF FLUORO AND RAD SYSTEM2Cleared 510(K)
- K993090SILHOUETTE FC2Cleared 510(K)
- K992066REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM2Cleared 510(K)
- K990715SHIMADZU CEILING TUBE SUPPORT CH-30GH2Cleared 510(K)
- K990298TOPOGRAPHIC IMAGING MARKER2Cleared 510(K)
- K990242TOPOGRAPHIC IMAGING MARKER2Cleared 510(K)
- K984111FV-RF2Cleared 510(K)
- K982955SILHOUETTE VR2Cleared 510(K)
- K982824X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID2Cleared 510(K)
- K981880DX-480, ADD ON DIGITAL IMAGER2Cleared 510(K)
- K982196DIGITAL RADIOGRAPHIC IMAGING SYSTEM2Cleared 510(K)
- K981657PHILIPS THORAVISION2Cleared 510(K)
- K981056VARIAN XIMATRON SCAN VISION CT2Cleared 510(K)
- K980296OLDELFT DIGIDELCA2Cleared 510(K)
- K974863IMIX DIGITAL THORAX SYSTEM2Cleared 510(K)
- K974597ADC COMPACT (AGFA DIAGNOSTIC CENTER)2Cleared 510(K)
- K974112VACUDAP, MODEL 2000, 20012Cleared 510(K)
- K973710DIGITAL ADD ON MULTI SYSTEM2Cleared 510(K)
- K970136DIGITAL ADD-ON BUCKY2Cleared 510(K)
- K973219AMBER DU2Cleared 510(K)
- K972766PIVOTING COMPENSATING FILTERS FOR THE HEAD2Cleared 510(K)
- K972000X-RAY ASSIST BAR2Cleared 510(K)
- K963941THE PHARAOH COMPENSATING FILTER2Cleared 510(K)
- K962896KODAK DIGITAL SCIENCE REMOTE CASSETTE2Cleared 510(K)
- K954196UNIVERSIX 1202Cleared 510(K)
- K953832SOLARIX FV2Cleared 510(K)
- K952871RIDGES PLUS2Cleared 510(K)
- K952672VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM2Cleared 510(K)
- K950980FAST FIND GRID2Cleared 510(K)
- K933512UPSCAN2Cleared 510(K)
- K944613SHOULDER RETRACTOR2Cleared 510(K)
- K945709SII 525 MS2Cleared 510(K)
- K945708SII 360 MS2Cleared 510(K)
- K945278PHILIPS BUCKY DIAGNOST FAMILY2Cleared 510(K)
- K942581BES - BREATH EXPOSURE SYNCHRONIZER2Cleared 510(K)
- K936087CARPAL BOX2Cleared 510(K)
- K931071PHILIPS THORAVISION2Cleared 510(K)
- K940306OCTOSTOP COMPENSATING FILTERS2Cleared 510(K)
- K942792BUCKY STAND BR-10M2Cleared 510(K)
- K941592WEIGHT BAG2Cleared 510(K)
- K941931DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR2Cleared 510(K)
- K935649WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY2Cleared 510(K)
- K933778WHITMORE ANKLE X-RAY EXTENSION (AXE)2Cleared 510(K)
- K934005SHIMADZU CEILING TUBE SUPPORT CH-30GX2Cleared 510(K)
- K934755FAST FIND GRIND2Cleared 510(K)
- K933023CERVICAL TRACTION STRAP2Cleared 510(K)
- K926554525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR2Cleared 510(K)
- K920347TOP-X 650HF RADIOGRAPHIC X-RAY2Cleared 510(K)
- K921112FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK2Cleared 510(K)
- K926069WRIST TRACTION2Cleared 510(K)
- K923455HFG 350, 650, 10502Cleared 510(K)
- K913435PXI URCD2Cleared 510(K)
- K913711GENTLE SLOPE2Cleared 510(K)
- K913659LITTLE PRISM2Cleared 510(K)
- K922813GEN-X 800-400 -- MODIFICATION2Cleared 510(K)
- K921539GEN-X 800/6/502Cleared 510(K)
- K915362VORTECH'S FILM DIGITIZER, FD-12Cleared 510(K)
- K920558KONICA DIRECT DIGITIZER KD-10002Cleared 510(K)
- K913757HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST2Cleared 510(K)
- K912517FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-91092Cleared 510(K)
- K912515FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-91102Cleared 510(K)
- K910757THE BULLION2Cleared 510(K)
- K904676NDI MODEL IRS-TD2Cleared 510(K)
- K904147HUGH YOUNG II UROLOGICAL X-RAY SYSTEM2Cleared 510(K)
- K904146NEURO VISION RADIOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K904145HYDRA VISION UROLOGICAL X-RAY SYSTEM2Cleared 510(K)
- K902791G.E. 48-4 CEILING TUBEHANGER2Cleared 510(K)
- K902606RADIOPAQUE RULER2Cleared 510(K)
- K902378CARDIOTHORACIC RULER2Cleared 510(K)
- K900562TRANS X 100 CHEST FILM CHANGER2Cleared 510(K)
- K884477SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B2Cleared 510(K)
- K883834MEDRAD OMNIPLANE 300 SYSTEM2Cleared 510(K)
- K883160CATAPULT BUCKY (KATAPULT BLENDA)2Cleared 510(K)
- K880352MTX GENERATOR2Cleared 510(K)
- K880982ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY2Cleared 510(K)
- K872525A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH2Cleared 510(K)
- K872317BC 1800 FINGER POSITIONER2Cleared 510(K)
- K872316BC 1400 HAND POSITIONER2Cleared 510(K)
- K872468JOVI MYELOGRAPHY HARNESS2Cleared 510(K)
- K870400SCX INFORMATION MANAGEMENT SYSTEM2Cleared 510(K)
- K870300BELMONT, PODIATRY X-RAY - REMEX, MODEL PD752Cleared 510(K)
- K863309REFURBISH DIAGNOSTIC X-RAY EQUIPMENT2Cleared 510(K)
- K862616AMBER-CHEST2Cleared 510(K)
- K861994MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM2Cleared 510(K)
- K860025MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR2Cleared 510(K)
- K854110KEITHLEY MODEL 75100 & 752002Cleared 510(K)
- K855161UPRIGHT BUCKY STAND/MOUNT2Cleared 510(K)
- K853330BOOMERANG ABSORPTION COMENSATION FILTER2Cleared 510(K)
- K853753DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 073022Cleared 510(K)
- K852349RHYNOSTAT H-12 & V-222Cleared 510(K)
- K841923DCX-100 CHEST UNIT-GL-5000M2Cleared 510(K)
- K841756LIEBEL-FLARSHEIM ACS 1000 CHEST X-RAY2Cleared 510(K)
- K833559ARMBOARD2Cleared 510(K)
- K813173VRT TABLE W/INTEGRATING TUBE STAND/ELEV2Cleared 510(K)
- K812332KERMATH L/C ARM2Cleared 510(K)
- K811934DSS 5002Cleared 510(K)
- K811807UROSKOP C2Cleared 510(K)
- K811230X-CELL X-RAY #'S P-75W/P-75M2Cleared 510(K)
- K811215KERMATH RADIOGRAPHIC HEAD STAND2Cleared 510(K)
- K811142BELMONT PODIATRY MODEL 065 X-RAY2Cleared 510(K)
- K810973SYSTEM 4002Cleared 510(K)
- K810797LOW DOSE SERVOCHEST2Cleared 510(K)
- K803049DIGITAL RADIOGRAPHY CHEST DEVICE2Cleared 510(K)
- K803130MULTIX U. BUCKY TABLE X-RAY UNIT2Cleared 510(K)
- K802200VERTIX 3D-U2Cleared 510(K)
- K800788SIREGRAPH C2Cleared 510(K)
- K800564GENERAL ELECTRIC RADVIEW MARK I SYSTEM2Cleared 510(K)
- K791374THE MTD VARA SET CASETTE HOLDER2Cleared 510(K)
- K790740BS 66, UNIVERSAL BUCKY STAND2Cleared 510(K)
- K790741COMPACT SYSTEM2Cleared 510(K)
- K790685POSI-TOT2Cleared 510(K)
- K790070SIREGRAPH B-1502Cleared 510(K)
- K790069BUCKYMAT2Cleared 510(K)
- K781983EXPLORAMAT, COSMIC 22Cleared 510(K)
- K781613SIREMAT2Cleared 510(K)
- K781473BUCKY WALL STAND2Cleared 510(K)
- K771051C-ARM X-RAY SYSTEM2Cleared 510(K)
- K770060X-RAY POSITIONING DEVICE2Cleared 510(K)
- K760205RADIOGRAPHIC UNIT, XRC-12Cleared 510(K)
- 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
DRX-Evolution with Carestream Digital Tomosynthesis
- Page Type
- Cleared 510(K)
- 510(k) Number
- K191879
- 510(k) Type
- Traditional
- Applicant
- Carestream Health, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/20/2019
- Days to Decision
- 158 days
- Submission Type
- Summary