510(k) Report

Devices descending from K003689

371 later devices reach Canon X-Ray Digital Camera, Model Cxdi-31 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation20180—
+7K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+7K171119GM85Samsung Electronics Co., Ltd.2017221
+7K170975Televere Digital Imaging SystemTelevere Systems20172—
+7K153492CareView 1800LCareray Digital Medical System Co., Ltd.20155—
+7K152279ViZion DR + WirelessViztek, LLC201527—
+7K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+8K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…DRTECH Corporation20260—
+8K260481GC85ASamsung Electronics Co., Ltd.20260—
+8K2538000909FCE, 0909FCE-HSRayence Co., Ltd.20260—
+8K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+8K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+8K242651GM85Samsung Electronics Co., Ltd.20240—
+8K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+8K232185SM-IVSedecal., Sa.20230—
+8K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+8K222951SM-VSedecal., Sa.20221—
+8K223060DigiX FDXAllengers Medical Systems Limited20224—
+8K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+8K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+8K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+8K200726AcuityPDRRadmedix, LLC20209—
+8K193173CareView 1800LeCareray Digital Medical System Co., Ltd.20194—
+8K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc.20180—
+8K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+8K172124Televere Podiatry Digital Imaging SystemTelevere Systems20170—
+8K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd.201624—
+8K160810ViZion DR + WirelessViztek, LLC20161—
+9K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+9K251443PROMODRGEM Corporation20250—
+9K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+9K230985Planmeca VisoPlanmeca Oy20233—
+9K231577MOBILETT ImpactSiemens Medical Solutions20230—
+9K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+9K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.20210—
+9K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+9K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+9K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+9K201058Accuvue+Radmedix, LLC20204—
+9K191645SKR 4000Konica Minolta, Inc.20190—
+9K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201818—
+9K182550Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.201812
+10K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+10K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+10K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+10K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+10K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+10K210919AcuityDReRadmedix, LLC20213—
+10K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd.20204—
+10K192512Focus 35C Detector, Trimax 35C DetectorIray Technology Taicang, Ltd.20190—
+10K190300BIOK7600W Wireless Flat Panel DetectorBiokinemetrics, Inc.20190—
+10K190311BIOK7600 Flat Panel DetectorBiokinemetrics, Inc.20190—
+10K183422Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20190—
+10K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd.20199—
+11K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+11K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—
+11K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+11K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+11K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20213—
+11K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd.20207—
+11K200622Focus 43C detector, TRIMAX 43C detectorIray Technology Taicang, Ltd.20200—
+12K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—
+12K221714Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+12K220668Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20221—
+12K213646Focus HD 35 DetectorIray Technology Taicang, Ltd.20220—
+12K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20214—
+13K222886Mercu 1717VIray Technology Taicang, Ltd.20220—
+13K221345Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd.20220—
+13K213529Focus HD 43 DetectorIray Technology Taicang, Ltd.20223—
+14K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+15K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—