510(k) Report

Devices descending from K031447

369 later devices reach Canon, Digital Radiography, Model Cxdi-50G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191939Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20199—
+7K181629GC85ASamsung Electronics Co., Ltd.20185—
+7K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+7K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+7K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+7K163157SmartGridCarestream Health20171—
+7K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+7K160997GC85ASamsung Electronics Co., Ltd.201626—
+7K160810ViZion DR + WirelessViztek, LLC20161—
+7K153464FDR D-EVO flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.20162—
+7K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.20150—
+8K260481GC85ASamsung Electronics Co., Ltd.20260—
+8K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+8K251443PROMODRGEM Corporation20250—
+8K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20250—
+8K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+8K230985Planmeca VisoPlanmeca Oy20233—
+8K231577MOBILETT ImpactSiemens Medical Solutions20230—
+8K222687Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20220—
+8K222661Digital Radiography CXDI-CS01Canon, Inc.20221—
+8K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+8K221876Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20221—
+8K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+8K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+8K201528Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20207—
+8K201591Flat Panel DetectorKa Imaging, Inc.20200—
+8K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+8K201058Accuvue+Radmedix, LLC20204—
+8K191645SKR 4000Konica Minolta, Inc.20190—
+8K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+8K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+8K180667SmartGridCarestream Health, Inc.20180—
+8K172229GC85ASamsung Electronics Co., Ltd.201721—
+8K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the…Fujifilm Medical Systems U.S.A, Inc.20170—
+8K170451FDX Console (DR-ID300CL) SoftwareFujifilm Medical Systems U.S.A, Inc.20170—
+8K163115GC70Samsung Electronics Co., Ltd.201623—
+9K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+9K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+9K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+9K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+9K230175Digital Radiography CXDI-CS01Canon, Inc.20230—
+9K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+9K222855Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20220—
+9K210919AcuityDReRadmedix, LLC20213—
+9K210988Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20215—
+9K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+9K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+9K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+9K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+9K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+9K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+10K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+10K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—
+10K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+10K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+10K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+10K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+10K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+11K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—
+11K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+11K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+11K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+11K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+12K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+12K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+12K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+13K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+14K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—