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
+5K113855Panorad, Panorad SLImix Adr Finland OY20120—
+5K112661Vizion DRViztek, LLC201134—
+6K252503Intelligent NRCanon, Inc.20260—
+6K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+6K250976Airbile-100Poskom Co., Ltd.20250—
+6K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20250—
+6K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—
+6K242119Innovision-ExiiDk Medical System20252—
+6K241068uDR 780iShanghai United Imaging Healthcare Co., Ltd.20241—
+6K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20242—
+6K232753Expd 4343D; Expd 3643DDRTECH Corporation20230—
+6K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation20230—
+6K230918MasterX 800 SeriesMedicatech USA20230—
+6K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFRayence Co., Ltd.20231—
+6K230241Jumong GeneralSg Healthcare Co, Ltd.20230—
+6K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation20222—
+6K222687Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20220—
+6K222661Digital Radiography CXDI-CS01Canon, Inc.20221—
+6K221853Otc DDRKonica Minolta Healthcare Americas, Inc.20220—
+6K221876Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20221—
+6K221335D²RS and D²RS 9090Stephanix20220—
+6K220271Hand Diagnostic Radiography Imaging SystemNanoray Biotech Co., Ltd.20220—
+6K220175GM85Samsung Electronics Co., Ltd.20223—
+6K2127530909FCB, 1212FCARayence Co., Ltd.20212—
+6K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+6K203188ADDH&abyz Co., Ltd.20213—
+6K201528Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20207—
+6K201591Flat Panel DetectorKa Imaging, Inc.20200—
+6K201503Edge Air (1417) Digital Flat Panel X-ray DetectorOsko, Inc.20200—
+6K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda20201—
+6K200418Vivix-S VWVieworks Co., Ltd.20204—
+6K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+6K193017Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WPDRTECH Corporation20191—
+6K193031Expd 4343P, Expd 3643PDRTECH Corporation20191—
+6K192011PhoeniXSedecal., Sa.20198—
+6K191813MobileDiagnost wDR 2.2Sedecal., Sa.201914
+6K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+6K190601MasteRad MX30Medicatech USA20190—
+6K183388JADE Mobile X-RayDRGEM Corporation20190—
+6K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+6K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+6K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+6K180667SmartGridCarestream Health, Inc.20180—
+6K172229GC85ASamsung Electronics Co., Ltd.201721—
+6K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+6K173187MobileDiagnost M50Philips India Limited20170—
+6K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+6K172581CareView 1800Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20170—
+6K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the…Fujifilm Medical Systems U.S.A, Inc.20170—
+6K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+6K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+6K170451FDX Console (DR-ID300CL) SoftwareFujifilm Medical Systems U.S.A, Inc.20170—
+6K162529DigiX FDXAllengers Medical Systems Limited20176—
+6K163703Vivix-S 1417NVieworks Co., Ltd.20175—
+6K163115GC70Samsung Electronics Co., Ltd.201623—
+6K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+6K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+6K162687Paragon 2Meridian Medical Systems, LLC20160—
+6K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…Agfa Healthcare N.V.20161—
+6K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc.20161—
+6K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorPerkinelmer, Inc.20160—
+6K162178CareView 1500P X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+6K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20158—
+6K151219Models 2200DR and 1600DR Digital Stationary Radiographic SystemsBeijing Polycon Medical Engineering Company20150—
+6K151221Kubtec DIGIVIEW 395Kub Technologies, Inc.20150—
+6K142718Radlink GPSRadlink, Inc.20141—
+6K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.20147—
+6K140825Delworks DR SystemDel Medical, Inc.20147—
+6K133139Vizion UltraViztek, LLC20140—
+6K123644Vizion + DRViztek, LLC201333—
+7K253446AeroDR TX c02Dk Medical Systems Co., Ltd.20260—
+7K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.20250—
+7K250790Innovision-DxiiDk Medical Systems Co., Ltd.20250—
+7K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation20250—
+7K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation20250—
+7K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+7K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20241—
+7K242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)Rayence Co., Ltd.20240—
+7K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+7K2403710909FCC, 0909FCC-HSRayence Co., Ltd.20241—
+7K233678Radiography 7000 MPhilips Medical Systems Dmc GmbH202401
+7K232082EXPD 4343SDRTECH Corporation20240—
+7K231959Expd 4357; Expd 4357PDRTECH Corporation20230—
+7K230175Digital Radiography CXDI-CS01Canon, Inc.20230—
+7K222855Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20220—
+7K222353GM85Samsung Electronics Co., Ltd.202223
+7K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd.20221—
+7K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.20222—
+7K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+7K212515MOVIX DReamyStephanix20210—
+7K212291PhoenixSedecal., Sa.202141
+7K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+7K211790DX-D Imaging Package with XD DetectorsAgfa N.V.20210—
+7K210988Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20215—
+7K203703I-Q ViewFirst Source, Inc.20210—
+7K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+7K192936Soltus 500Sedecal., Sa.201901
+7K192541DigiX FDXAllengers Medical Systems Limited20195—
+7K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+7K181629GC85ASamsung Electronics Co., Ltd.20185—