510(k) Report

Devices descending from K992547

393 later devices reach Canon X-Ray Digital Camera, Model Cxdi-22 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201432—
+8K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+9K2538000909FCE, 0909FCE-HSRayence Co., Ltd.20260—
+9K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+9K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20250—
+9K243171Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20241—
+9K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+9K240771PRORAD X-Ray Flat Panel Detector with DROCPrognosys Medical Systems Private Limited20240—
+9K242651GM85Samsung Electronics Co., Ltd.20240—
+9K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+9K232185SM-IVSedecal., Sa.20230—
+9K223009Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20221—
+9K222951SM-VSedecal., Sa.20221—
+9K223060DigiX FDXAllengers Medical Systems Limited20224—
+9K222687Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20220—
+9K222661Digital Radiography CXDI-CS01Canon, Inc.20221—
+9K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+9K221876Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20221—
+9K210619SKR 3000Konica Minolta, Inc.20212—
+9K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+9K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+9K200726AcuityPDRRadmedix, LLC20209—
+9K200668DR-ID 1200SDK SystemFujifilm Corporation20200—
+9K193173CareView 1800LeCareray Digital Medical System Co., Ltd.20194—
+9K192932FDR D-EVO III flat panel detector systemFujifilm Corporation20190—
+9K192440FDR SE LiteFujifilm Corporation20190—
+9K191939Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20199—
+9K191645SKR 4000Konica Minolta, Inc.20190—
+9K181629GC85ASamsung Electronics Co., Ltd.20185—
+9K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+9K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+9K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+9K163157SmartGridCarestream Health20171—
+9K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+9K160997GC85ASamsung Electronics Co., Ltd.201626—
+9K160810ViZion DR + WirelessViztek, LLC20161—
+9K153464FDR D-EVO flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.20162—
+9K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.20150—
+10K260481GC85ASamsung Electronics Co., Ltd.20260—
+10K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+10K251443PROMODRGEM Corporation20250—
+10K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20250—
+10K230985Planmeca VisoPlanmeca Oy20233—
+10K231577MOBILETT ImpactSiemens Medical Solutions20230—
+10K230175Digital Radiography CXDI-CS01Canon, Inc.20230—
+10K222855Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20220—
+10K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+10K213908SKR 3000Konica Minolta, Inc.20221—
+10K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+10K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+10K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+10K201528Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20207—
+10K201591Flat Panel DetectorKa Imaging, Inc.20200—
+10K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+10K201058Accuvue+Radmedix, LLC20204—
+10K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+10K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+10K180667SmartGridCarestream Health, Inc.20180—
+10K172229GC85ASamsung Electronics Co., Ltd.201721—
+10K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the…Fujifilm Medical Systems U.S.A, Inc.20170—
+10K170451FDX Console (DR-ID300CL) SoftwareFujifilm Medical Systems U.S.A, Inc.20170—
+10K163115GC70Samsung Electronics Co., Ltd.201623—
+11K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+11K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+11K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+11K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+11K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+11K223267SKR 3000Konica Minolta, Inc.20220—
+11K210919AcuityDReRadmedix, LLC20213—
+11K210988Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20215—
+11K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+11K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+11K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+11K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+11K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+11K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+12K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+12K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—
+12K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+12K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+12K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+12K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+12K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+13K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—
+13K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+13K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+13K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+13K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+14K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+14K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+14K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+15K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+16K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—