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
+3K103597DX-D 100Agfa Healthcare N.V.201116
+3K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+3K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+3K102012Digital RadiographyCanon Inc. -Medical Equipment Group2010801
+3K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+3K091752Viztek WLViztek, Inc.20090—
+3K082261Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd.20080—
+3K082798Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000Medicatech USA20080—
+4K260482DRE DuoJpi Healthcare Co, Ltd.20260—
+4K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+4K230800Xvision-525, Horizon, HI-300, HI-500, Saturn-F PF32, Saturn-F PF40, Saturn-F PF50Gemss Healthcare CO., LTD.20230—
+4K223842DRX - CompassCarestream Health, Inc.20231—
+4K212940Skanmobile, Skanmobile-DrSkanray Technologies Limited20220—
+4K214012Straight Arm DDRKonica Minolta Healthcare Americas, Inc.20221—
+4K213479D²RS and D²RS 9090Stephanix20211—
+4K2109851717FCCRayence Co., Ltd.20210—
+4K202388Apolo D / Apolo SVmi Tecnologias Ltda20200—
+4K2027221212FCARayence Co., Ltd.20203—
+4K202293Radiographic System Challenge XSedecal., Sa.20200—
+4K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20208—
+4K202156Diamond-5A/6A/8ADRGEM Corporation20201—
+4K2017961717SCV, 1717SGVRayence Co., Ltd.20200—
+4K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit.202003
+4K200787BSD3543WBontech Co., Ltd.20200—
+4K200887AS-10Canon, Inc.20200—
+4K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20200—
+4K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation20196—
+4K191884DR 100sAgfa N.V.20190—
+4K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+4K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+4K182880Halifax Imaging KitHalifax Biomedical, Inc.20180—
+4K182647GC70Samsung Electronics Co., Ltd.20180—
+4K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+4K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH20183—
+4K181631GR40CWSamsung Electronics Co., Ltd.20185—
+4K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+4K173953uDR 780iShanghai United Imaging Healthcare Co., Ltd.20182—
+4K172681Edge Air Digital Flat Panel X-ray DetectorOsko, Inc.20171—
+4K172682Edge Digital Flat Panel X-ray DetectorOsko, Inc.20170—
+4K1714181417WCC_127um and1417WCC_140umRayence Co., Ltd.20172—
+4K1714171417WGC_127um and 1417WGC_140umRayence Co., Ltd.20170—
+4K162344Innolux RicInnolux Corporation20161—
+4K162552Evs 3643, Evs 3643GDRTECH Corporation20163—
+4K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+4K152894Vivix-S 1717NVieworks Co., Ltd.20169—
+4K152855Vivix-S 1012NVieworks Co., Ltd.20165—
+4K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+4K150929CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.201512—
+4K150816Jumong SeriesSg Healthcare Co, Ltd.20152—
+4K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+4K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemMedicatech USA20152—
+4K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+4K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+4K141895Mobilediagnost WDRSedecal., Sa.201432
+4K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20142—
+4K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc.201412—
+4K141566Solid State X-Ray Imaging Device, Digiital Flat Panel X-Ray Detector, 1417WCCRayence Co., Ltd.20140—
+4K141563Solid State X-Ray Imaging Device, Digital Flat Panel X-Ray Detector, 1417WGCRayence Co., Ltd.20140—
+4K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…Canon, Inc.201321—
+4K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+4K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+4K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+4K113855Panorad, Panorad SLImix Adr Finland OY20120—
+4K112661Vizion DRViztek, LLC201134—
+4K112309Digital RadiographyCanon Inc. -Medical Equipment Group201122—
+4K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc.201152—
+4K103591Digital RadiographyCanon Inc. -Medical Equipment Group201124—
+4K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc.201154—
+5K252503Intelligent NRCanon, Inc.20260—
+5K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+5K250976Airbile-100Poskom Co., Ltd.20250—
+5K241980!M1Solutions For Tomorrow AB20251—
+5K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—
+5K242119Innovision-ExiiDk Medical System20252—
+5K241068uDR 780iShanghai United Imaging Healthcare Co., Ltd.20241—
+5K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20242—
+5K232753Expd 4343D; Expd 3643DDRTECH Corporation20230—
+5K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation20230—
+5K230918MasterX 800 SeriesMedicatech USA20230—
+5K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFRayence Co., Ltd.20231—
+5K230241Jumong GeneralSg Healthcare Co, Ltd.20230—
+5K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation20222—
+5K221853Otc DDRKonica Minolta Healthcare Americas, Inc.20220—
+5K221335D²RS and D²RS 9090Stephanix20220—
+5K220271Hand Diagnostic Radiography Imaging SystemNanoray Biotech Co., Ltd.20220—
+5K220175GM85Samsung Electronics Co., Ltd.20223—
+5K2127530909FCB, 1212FCARayence Co., Ltd.20212—
+5K212269Intelligent NRCanon, Inc.20210—
+5K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+5K203188ADDH&abyz Co., Ltd.20213—
+5K201503Edge Air (1417) Digital Flat Panel X-ray DetectorOsko, Inc.20200—
+5K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda20201—
+5K200418Vivix-S VWVieworks Co., Ltd.20204—
+5K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+5K193017Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WPDRTECH Corporation20191—
+5K193031Expd 4343P, Expd 3643PDRTECH Corporation20191—
+5K192011PhoeniXSedecal., Sa.20198—
+5K191813MobileDiagnost wDR 2.2Sedecal., Sa.201914
+5K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+5K190601MasteRad MX30Medicatech USA20190—