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
- K252911Lux HD 2530 detector (Lux HD 2530)2Cleared 510(K)
- K250211Yushan X-Ray Flat Panel Detector2Cleared 510(K)
- K250665SKR 30002Cleared 510(K)
- K243734Wireless/ Wired X-Ray Flat Panel Detectors2Cleared 510(K)
- K242770EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG2Cleared 510(K)
- K243443EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP2Cleared 510(K)
- K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)2Cleared 510(K)
- K244010ExamVue Apex2Cleared 510(K)
- K243171Yushan X-Ray Flat Panel Detector2Cleared 510(K)
- K241319SKR 30002Cleared 510(K)
- K241125VIVIX-S 1751S2Cleared 510(K)
- K240771PRORAD X-Ray Flat Panel Detector with DROC2Cleared 510(K)
- K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)2Cleared 510(K)
- K242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)2Cleared 510(K)
- K2403710909FCC, 0909FCC-HS2Cleared 510(K)
- K232082EXPD 4343S2Cleared 510(K)
- K232753EXPD 4343D; EXPD 3643D2Cleared 510(K)
- K230918MasterX 800 Series2Cleared 510(K)
- K232058YosemiteView 4343W/YosemiteView 3643W2Cleared 510(K)
- K231959EXPD 4357; EXPD 4357P2Cleared 510(K)
- K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G42Cleared 510(K)
- K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF2Cleared 510(K)
- K223930A1417MCW/A1717MCW/F1417MCW2Cleared 510(K)
- K230175Digital Radiography CXDI-CS012Cleared 510(K)
- K230059Digital Flat Panel Detector2Cleared 510(K)
- K22354614HQ721G-B2Cleared 510(K)
- K223687X-ray Flat Panel Detectors (EverestView 4343X)2Cleared 510(K)
- K223009Wireless/Wired X-Ray Flat Panel Detectors2Cleared 510(K)
- K223124EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG2Cleared 510(K)
- K223267SKR 30002Cleared 510(K)
- K222886Mercu 1717V2Cleared 510(K)
- K222855Digital Radiography CXDI-Pro, Digital Radiography D12Cleared 510(K)
- K222687Digital Radiography CXDI-Elite, Digital Radiography E12Cleared 510(K)
- K222661Digital Radiography CXDI-CS012Cleared 510(K)
- K220239Solid State X-ray Imager(Model: FXRD-4386WB)2Cleared 510(K)
- K221549X-ray Flat Panel Detectors (CareView 1800 RF)2Cleared 510(K)
- K22146110HQ701G-B2Cleared 510(K)
- K22139414HQ701G-B2Cleared 510(K)
- K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)2Cleared 510(K)
- K221876Digital Radiography CXDI-Pro, Digital Radiography D12Cleared 510(K)
- K22143417HQ701G-B2Cleared 510(K)
- K221714Flat Panel Detector2Cleared 510(K)
- K221345Wireless Digital Flat Panel Detector2Cleared 510(K)
- K221620Digital Radiography CXDI-Elite, Digital Radiography E12Cleared 510(K)
- K221144PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG2Cleared 510(K)
- K22055917HQ901G-B2Cleared 510(K)
- K220536Digital flat panel detector2Cleared 510(K)
- K220510Yushan X-Ray Flat Panel Detector with DROC2Cleared 510(K)
- K220668Wireless Digital Flat Panel Detector2Cleared 510(K)
- K213529Focus HD 43 Detector2Cleared 510(K)
- K213646Focus HD 35 Detector2Cleared 510(K)
- K21404414HQ901G-B2Cleared 510(K)
- K220098Digital Radiography CXDI-Pro, Digital Radiography D12Cleared 510(K)
- K213908SKR 30002Cleared 510(K)
- K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E12Cleared 510(K)
- K214030Universal DR 17482Cleared 510(K)
- K213307Eclipse II with Smart Noise Cancellation2Cleared 510(K)
- K213469VALORY2Cleared 510(K)
- K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)2Cleared 510(K)
- K2127530909FCB, 1212FCA2Cleared 510(K)
- K212269Intelligent NR2Cleared 510(K)
- K212553DIGITAL RADIOGRAPHY CXDI-Pro, D12Cleared 510(K)
- K212051RFA-1717DIG, RFA-1717DIC2Cleared 510(K)
- K210619SKR 30002Cleared 510(K)
- K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF2Cleared 510(K)
- K211790DX-D Imaging Package with XD Detectors2Cleared 510(K)
- K211542PRIMO S2Cleared 510(K)
- K211108Prudent 1717, Prudent 1417, Prudent 12122Cleared 510(K)
- K210919AcuityDRe2Cleared 510(K)
- K2109851717FCC2Cleared 510(K)
- K210988Yushan X-Ray Flat Panel Detector with DROC2Cleared 510(K)
- K202441Eclipse II with Smart Noise Cancellation2Cleared 510(K)
- K203703I-Q View2Cleared 510(K)
- K203188ADD2Cleared 510(K)
- K210316Mars 1417X Wireless Digital Flat Panel Detector2Cleared 510(K)
- K210314Mars1717X Wireless Digital Flat Panel Detector2Cleared 510(K)
- K202995X-ray Flat Panel Detectors/CareView 3600RF2Cleared 510(K)
- K203849General Radiography CXDI-CS012Cleared 510(K)
- K203159Lux 35 Detector2Cleared 510(K)
- K2027221212FCA2Cleared 510(K)
- K201528Yushan X-Ray Flat Panel Detector with DROC2Cleared 510(K)
- K202564DigitalDiagnost C902Cleared 510(K)
- K201591Flat Panel Detector2Cleared 510(K)
- K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)2Cleared 510(K)
- K2017961717SCV, 1717SGV2Cleared 510(K)
- K201503Edge Air(1417) Digital Flat Panel X-ray Detector2Cleared 510(K)
- K201247Intraoral Sensor2Cleared 510(K)
- K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)2Cleared 510(K)
- K201058Accuvue+2Cleared 510(K)
- K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W2Cleared 510(K)
- K200787BSD3543W2Cleared 510(K)
- K200668DR-ID 1200SDK System2Cleared 510(K)
- K200622Focus 43C detector, TRIMAX 43C detector2Cleared 510(K)
- K200418VIVIX-S VW2Cleared 510(K)
- K192894Vita Flex CR System with LLI2Cleared 510(K)
- K193644E-COM DR-2000 DR2Cleared 510(K)
- K200018HAD1717MC2Cleared 510(K)
- K193238Nexus DR Digital X-Ray Imaging System (with vSharp)2Cleared 510(K)
- K193173CareView 1800Le2Cleared 510(K)
- K193031EXPD 4343P, EXPD 3643P2Cleared 510(K)
- K193017EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP2Cleared 510(K)
- K192932FDR D-EVO III flat panel detector system2Cleared 510(K)
- K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless2Cleared 510(K)
- K192440FDR SE Lite2Cleared 510(K)
- K192512Focus 35C Detector, Trimax 35C Detector2Cleared 510(K)
- K192400EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG2Cleared 510(K)
- K191939Yushan X-Ray Flat Panel Detector2Cleared 510(K)
- K191645SKR 40002Cleared 510(K)
- K190611VIVIX-S 1751S2Cleared 510(K)
- K190691Pixx2430 Digital Diagnostic X-Ray Receptor Panel2Cleared 510(K)
- K190368Enhanced Feature Software Pack CXDI Series2Cleared 510(K)
- K190300BIOK7600W Wireless Flat Panel Detector2Cleared 510(K)
- K190311BIOK7600 Flat Panel Detector2Cleared 510(K)
- K190146Nexus DR Digital X-ray Imaging System2Cleared 510(K)
- K183245Carestream DRX-1 System with DRX Plus 2530 Detectors2Cleared 510(K)
- K183474Carestream DRX-1 System with DRX Core Detectors2Cleared 510(K)
- K182973DigitalDiagnost C902Cleared 510(K)
- K183422Wireless Digital Flat Panel Detector2Cleared 510(K)
- K183713Wireless Digital Flat Detector2Cleared 510(K)
- K182688SKR 30002Cleared 510(K)
- K18328617HK701G-W2Cleared 510(K)
- K183212Nexus DR Digital X-ray Imaging System with stitching2Cleared 510(K)
- K18234814HK701G-W2Cleared 510(K)
- K182550Wireless Digital Flat Panel Detector2Cleared 510(K)
- K182551Wireless Digital Flat Panel Detector2Cleared 510(K)
- K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels2Cleared 510(K)
- K181631GR40CW2Cleared 510(K)
- K181565Aquarius 8600 Digital Radiography Sensor2Cleared 510(K)
- K181526XRpad2 4343 HWC-M Flat Panel Detector2Cleared 510(K)
- K180809Eclipse II2Cleared 510(K)
- K180989PEDRA-17F Digital Flat Panel X-ray Detector2Cleared 510(K)
- K18033217HK700G-W2Cleared 510(K)
- K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels2Cleared 510(K)
- K181003VIVIX-S 1717V2Cleared 510(K)
- K180667SmartGrid2Cleared 510(K)
- K171270DIGITAL RADIOGRAPHY CXDI-410C WIRELESS2Cleared 510(K)
- K173273Aquarius 8600 1417WCI; Aquarius 8600 1717WCI2Cleared 510(K)
- K172124Televere Podiatry Digital Imaging System2Cleared 510(K)
- K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)2Cleared 510(K)
- K172784DX-D Imaging Package2Cleared 510(K)
- K172435Galaxy R Digital Radiography Upgrade2Cleared 510(K)
- K172793SKR 30002Cleared 510(K)
- K171169Aquarius 8600 1417TG and Aquarius 8600 1717TG2Cleared 510(K)
- K172681Edge Air Digital Flat Panel X-ray Detector2Cleared 510(K)
- K172682Edge Digital Flat Panel X-ray Detector2Cleared 510(K)
- K171175Aquarius 8600 1417WC2Cleared 510(K)
- K172581CareView 1800Cw X-ray Flat Panel Detectors2Cleared 510(K)
- K171716SKR 30002Cleared 510(K)
- K171461SkyPlate Detector for Philips Radiography/Fluoroscopy Systems2Cleared 510(K)
- K170480Models 3543A, 4343A, 2929A and A843B2Cleared 510(K)
- K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)2Cleared 510(K)
- K171485BSD4343R Digital Flat Panel X-ray Detector2Cleared 510(K)
- K1714171417WGC_127um and 1417WGC_140um2Cleared 510(K)
- K1714181417WCC_127um and1417WCC_140um2Cleared 510(K)
- K1714191717SGC_127um and 1717SGC_140um2Cleared 510(K)
- K1714201717SCC_127um and 1717SCC_140um2Cleared 510(K)
- K171138Nexus DR Digital X-ray Imaging System2Cleared 510(K)
- K171137EVS 2430W, EVS 2430GW2Cleared 510(K)
- K171085GMR402Cleared 510(K)
- K170975Televere Digital Imaging System2Cleared 510(K)
- K163157SmartGrid2Cleared 510(K)
- K170332DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS2Cleared 510(K)
- K170202Aquarius 86002Cleared 510(K)
- K170113pixium 4343RCE2Cleared 510(K)
- K163703VIVIX-S 1417N2Cleared 510(K)
- K162909CSX-30 Flat Panel Detector2Cleared 510(K)
- K162555EVS 4343, EVS 4343G2Cleared 510(K)
- K162344INNOLUX RIC2Cleared 510(K)
- K161730Wireless Digital Flat Panel Detector2Cleared 510(K)
- K162552EVS 3643, EVS 3643G2Cleared 510(K)
- K163019CareView 750Cw/750C X-ray Flat Panel Detectors2Cleared 510(K)
- K160143ClearVision ExamVue Flat Panel Detector2Cleared 510(K)
- K162487BSD3543 Digital Flat Panel X-ray Detector2Cleared 510(K)
- K1625191717WCC / 1717WGC2Cleared 510(K)
- K1625181012WCC, 1012WGC2Cleared 510(K)
- K162504SKR 30002Cleared 510(K)
- K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)2Cleared 510(K)
- K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector2Cleared 510(K)
- K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)2Cleared 510(K)
- K162178CareView 1500P X-ray Flat Panel Detectors2Cleared 510(K)
- K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector2Cleared 510(K)
- K153312SCATTER CORRECTION FOR CXDI SERIES2Cleared 510(K)
- K160204BSD4343 Digital Flat Panel X-ray Detector2Cleared 510(K)
- K160810ViZion DR + Wireless2Cleared 510(K)
- K153464FDR D-EVO flat Panel Detector System2Cleared 510(K)
- K153710Tuxedo Digital Dental Sensor2Cleared 510(K)
- K152894VIVIX-S 1717N2Cleared 510(K)
- K152855VIVIX-S 1012N2Cleared 510(K)
- K153492CareView 1800L2Cleared 510(K)
- K153318Philips Eleva Workspot with SkyFlow2Cleared 510(K)
- K153401GR40CW2Cleared 510(K)
- K152639DR 6002Cleared 510(K)
- K153142Carestream DRX-1 System with DRX Plus 4343 Detectors2Cleared 510(K)
- K153058CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors2Cleared 510(K)
- K152151ATAL 92Cleared 510(K)
- K152138FDR D-EVO GL Flat Panel Detector System2Cleared 510(K)
- K151942EVS 36432Cleared 510(K)
- K152094GR40CW2Cleared 510(K)
- K152279ViZion DR + Wireless2Cleared 510(K)
- K141488CAREVIEW 1800R2Cleared 510(K)
- K150929CareView 1500Cw X-ray Flat Panel Detectors2Cleared 510(K)
- K151014Aura DR 43C-AG flat panel detector2Cleared 510(K)
- K151465AeroDR SYSTEM 22Cleared 510(K)
- K150766Carestream DRX-1 System2Cleared 510(K)
- K151221Kubtec DIGIVIEW 3952Cleared 510(K)
- K1501501717SGN / 1717SCN Digital Flat Panel X-ray Detector2Cleared 510(K)
- K143232Universal Digital Interface 2W, UDI 2W2Cleared 510(K)
- K143000RIS5002Cleared 510(K)
- K142475EVS 43432Cleared 510(K)
- K142718Radlink GPS2Cleared 510(K)
- K142698PerkinElmer, XRpad 4343 F MED Flat Panel Detector2Cleared 510(K)
- K140251UNIVERSAL DIGITAL INTERFACE 2, UDI 22Cleared 510(K)
- K142003FDR D-EVO II FLAT PANEL DETECTOR SYSTEM2Cleared 510(K)
- K142184DX-D IMAGING PACKAGE2Cleared 510(K)
- K141765FDR D-EVO FLAT PANEL DETECTOR SYSTEM2Cleared 510(K)
- K141743FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT2Cleared 510(K)
- K141271AERODR SYSTEM 22Cleared 510(K)
- K141602DX-D IMAGING PACKAGE2Cleared 510(K)
- K141440DICOMPACS DX-R WITH FLAT PANEL2Cleared 510(K)
- K141435OPAL CHIRO, 20/20 P-DR2Cleared 510(K)
- K140551PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR2Cleared 510(K)
- K141736PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST2Cleared 510(K)
- K140825DELWORKS DR SYSTEM2Cleared 510(K)
- K141563SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC2Cleared 510(K)
- K141566SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC2Cleared 510(K)
- K133693DIGITAL RADIOGRAPHY CXDI-401C WIRELESS2Cleared 510(K)
- K141192DR 4002Cleared 510(K)
- K140235XGEO GR40CW2Cleared 510(K)
- K140060DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A2Cleared 510(K)
- K140056DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A2Cleared 510(K)
- K140771PHILIPS ELEVA WORKSPOT2Cleared 510(K)
- K133524PVMED DDR 2430T2Cleared 510(K)
- K140646DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G2Cleared 510(K)
- K133139VIZION ULTRA2Cleared 510(K)
- K133782NOVA FA DR SYSTEM2Cleared 510(K)
- K133442BONE SUPPRESSION SOFTWARE2Cleared 510(K)
- K133409DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA2Cleared 510(K)
- K132842FLAATZ 600 SERIES (FLAATZ 600/601)2Cleared 510(K)
- K132921GALAXY PLUS2Cleared 510(K)
- K133120COMPUTED RADIOGRAPHY SCANNER2Cleared 510(K)
- K133106COMPUTED RADIOGRAPHY SCANNER2Cleared 510(K)
- K132509FDR D-EVO FLAT PANEL DETECTOR SYSTEM2Cleared 510(K)
- K131211DICOMPACS DX-R WITH FLAT PANEL2Cleared 510(K)
- K131483PHILIPS PIXIUM 4343RC2Cleared 510(K)
- K131114DIGITAL FLAT PANEL X-RAY DETECTOR2Cleared 510(K)
- K131408CR 12-X DIGITIZER2Cleared 510(K)
- K130936AERODR SYSTEM WITH P-312Cleared 510(K)
- K131106DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,2Cleared 510(K)
- K130935DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA2Cleared 510(K)
- K131314DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)2Cleared 510(K)
- K130567DR LONG LENGTH IMAGING SOFTWARE2Cleared 510(K)
- K130464CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR2Cleared 510(K)
- K130377KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM2Cleared 510(K)
- K130883SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T2Cleared 510(K)
- K123345DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA2Cleared 510(K)
- K122736DX-D IMAGING PACKAGE2Cleared 510(K)
- K123740EOS2Cleared 510(K)
- K122865VIVIX-S WIRELESS2Cleared 510(K)
- K122928DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA2Cleared 510(K)
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- K122866VIVIX-S WITH VXVUE2Cleared 510(K)
- K122919DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA2Cleared 510(K)
- K123499AEROPILOT2Cleared 510(K)
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- K120629FDR GO FLEX2Cleared 510(K)
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- K121948CR 10-X DIGITIZER2Cleared 510(K)
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- K113449FUSION FLAT PANEL2Cleared 510(K)
- K112527UNIVERSAL DIGITAL INTERFACE (UDI) 17172Cleared 510(K)
- K121132EZSENSOR P DIGITAL INTRAORAL SENSOR2Cleared 510(K)
- K120020VIVIX-S2Cleared 510(K)
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- K102327CLEARVISION DR 7000F2Cleared 510(K)
- K120477AEROSYNC FOR AERODR SYSTEM2Cleared 510(K)
- K120721EOS2Cleared 510(K)
- K120380SATURN 80002Cleared 510(K)
- K120131REGIUS SIGMA22Cleared 510(K)
- K111305UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W2Cleared 510(K)
- K113630DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA2Cleared 510(K)
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- K112309DIGITAL RADIOGRAPHY2Cleared 510(K)
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- K111548WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE2Cleared 510(K)
- K110801WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM2Cleared 510(K)
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- K111098INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN2Cleared 510(K)
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- K103599UNIVERSAL DIGITAL INTERFACE (UDI) 17172Cleared 510(K)
- K110210SATURN 8000-GS2Cleared 510(K)
- K103596WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR2Cleared 510(K)
- K103591DIGITAL RADIOGRAPHY2Cleared 510(K)
- K102474FLAATZ 750E2Cleared 510(K)
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- K102615WIRELESS DR IMAGING OPTION-WDR12Cleared 510(K)
- K102012DIGITAL RADIOGRAPHY2Cleared 510(K)
- K091090DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 17172Cleared 510(K)
- K101289SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB2Cleared 510(K)
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- K100001MOBIVISION2Cleared 510(K)
- K093790SIMONDR DRP2Cleared 510(K)
- K093427FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR2Cleared 510(K)
- K092669DX-D IMAGING PACKAGE2Cleared 510(K)
- K092717DIRECT DIGITIZER, REGIUS MODEL 2102Cleared 510(K)
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- K092238AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS2Cleared 510(K)
- K082450IDR2Cleared 510(K)
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- K091435DIGITAL RADIOGRAPHY MODEL CXDI-55G2Cleared 510(K)
- K091436DIGITAL RADIOGRAPHY, MODEL CXDI-55C2Cleared 510(K)
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- K090318CARESTREAM DRX-1 SYSTEM2Cleared 510(K)
- K090623DIGITAL RADIOGRAPHY CXDI-40G COMPACT2Cleared 510(K)
- K090625WIRELESS PORTABLE DETECTOR FD-W172Cleared 510(K)
- K083224CPI RAD VISION, MODEL VZW2944XX-YY2Cleared 510(K)
- K083645RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS2Cleared 510(K)
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- K082494DRAD3000E/RADREX-I2Cleared 510(K)
- K081963AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS2Cleared 510(K)
- K081648DIGITAL RADIOGRAPHY CXDI-60G2Cleared 510(K)
- K081624INFX-8000F (INFINIX CSI AND INFINIX DPI)2Cleared 510(K)
- K080589SATURN 9000-8102Cleared 510(K)
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- K072983SATURN 9000-7502Cleared 510(K)
- K071682CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)2Cleared 510(K)
- K063710SATURN 90002Cleared 510(K)
- K071193VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS2Cleared 510(K)
- K071181DIRECT DIGITIZER, REGIUS MODEL 1102Cleared 510(K)
- K070829SYNEPIX 4600 DETECTOR2Cleared 510(K)
- K071162AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS2Cleared 510(K)
- K070563VIDAR VISION 20002Cleared 510(K)
- K070528PHILIPS ESSENTA DR2Cleared 510(K)
- K070079X3C DIGITAL RADIOGRAPHIC DETECTOR2Cleared 510(K)
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- K062376DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI2Cleared 510(K)
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- K062390CRYSTALVIEW R2002Cleared 510(K)
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- K062221CXDI-40EC2Cleared 510(K)
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- K052661QUIX DIGITAL RADIOGRAPHIC UPGRADE2Cleared 510(K)
- K061054AXIOM ARISTOS FX PLUS2Cleared 510(K)
- K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWARE2Cleared 510(K)
- K060433DIGITAL RADIOGRAPHY CXDI-50C2Cleared 510(K)
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- K053029NDR+/DIVA-D2Cleared 510(K)
- K052938CR-PRO2Cleared 510(K)
- K051998REGIUS MODEL 170 DIRECT DIGITIZER2Cleared 510(K)
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- K051494MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 70012Cleared 510(K)
- K052136GR17 DIGITAL DETECTOR2Cleared 510(K)
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- K042791INSTANT-X, MODELS 1713 & 1282Cleared 510(K)
- K051483KODAK DIRECTVIEW DR SYSTEM DETECTOR2Cleared 510(K)
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- K042602REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING2Cleared 510(K)
- K042386DIRECT DIGITIZER, REGIUS MODEL 1902Cleared 510(K)
- K042821DIGITAL DETECTOR, MODEL GR172Cleared 510(K)
- K042397SCANX 142Cleared 510(K)
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- K042023FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER2Cleared 510(K)
- K041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM2Cleared 510(K)
- K033561FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER2Cleared 510(K)
- K032210ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM2Cleared 510(K)
- K031198SCANX 102Cleared 510(K)
- K031633CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C2Cleared 510(K)
- K031447CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G2Cleared 510(K)
- K024147PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K023750CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G2Cleared 510(K)
- K023586DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS2Cleared 510(K)
- K023061KONICA DIRECT DIGITIZER REGIUS, MODEL 1702Cleared 510(K)
- K023124CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT2Cleared 510(K)
- K021829MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM2Cleared 510(K)
- K013897SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW2Cleared 510(K)
- K020635KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 11709762Cleared 510(K)
- K013054KONICA DIRECT DIGITIZER REGIUS MODEL 3502Cleared 510(K)
- K013218FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II2Cleared 510(K)
- K012750ADC PEDIATRIC2Cleared 510(K)
- K003238SOLID STATE X-RAY IMAGING DEVICES2Cleared 510(K)
- K013138ADC COMPACT PLUS2Cleared 510(K)
- K003438SMART RAD2Cleared 510(K)
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- K003256PCCR DIGITAL IMAGING DEVICE2Cleared 510(K)
- K992955XPLORER 10002Cleared 510(K)
- K993861FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER2Cleared 510(K)
- K992794STINGRAY DR, MODEL 12Cleared 510(K)
- K992547CANON X-RAY DIGITAL CAMERA, MODEL CXDI-222Cleared 510(K)
- K990359KONICA DIRECT DIGITIZER, MODEL DD-3412Cleared 510(K)
- K983732THORAX FD AND MULTIX FD2Cleared 510(K)
- K982661CDR - PAN MODEL 47002Cleared 510(K)
- K982795PHILIPS BUCKY VISION2Cleared 510(K)
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- 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
Focus HD 35 Detector
- Page Type
- Cleared 510(K)
- 510(k) Number
- K213646
- 510(k) Type
- Special
- Applicant
- iRay Technology Taicang Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/29/2022
- Days to Decision
- 145 days
- Submission Type
- Summary