510(k) Report

Devices descending from K023750

390 later devices reach Cannon Digital Radiography Model Cxdi-40G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162487BSD3543 Digital Flat Panel X-ray DetectorBontech, Inc.20161—
+4K1625181012WCC, 1012WGCRayence Co., Ltd.20164—
+4K1625191717WCC / 1717WGCRayence Co., Ltd.20162—
+4K151942EVS 3643DRTECH Corporation20154—
+4K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+4K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+4K141271Aerodr System 2Konica Minolta, Inc.201412—
+4K140646Digital Flat Panel X-Ray Detector / 1717G, XMARU1717GRayence Co., Ltd.20140—
+4K133782Nova FA DR SystemSedecal., Sa.2014111
+4K133409Digital Flat Panel X-Ray Detector/ 910SGARayence Co., Ltd.20140—
+4K131211Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20133—
+4K131114Digital Flat Panel X-Ray DetectorRayence Co., Ltd.20132—
+4K130936Aerodr System with P-31Konica Minolta Medical & Graphic, Inc.201313—
+4K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…Canon, Inc.201321—
+4K130935Digital Flat Panel X-Ray Detector/1417WCARayence Co., Ltd.20134—
+4K122865Vivix-S WirelessVieworks Co., Ltd.201328—
+4K122866Vivix-S with VxvueVieworks Co., Ltd.201311—
+4K123499AeropilotKonica Minolta Medical & Graphic, Inc.20120—
+4K122495Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc.201213—
+4K121345SR Suite 1.0Halifax Biomedical, Inc.20121—
+4K120477Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc.201214—
+4K113855Panorad, Panorad SLImix Adr Finland OY20120—
+4K113248Aerodr System with P-21Konica Minolta Medical & Graphic, Inc.201214—
+4K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+4K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa.2011164
+4K111725Mobilediagnost WDRSedecal., Sa.201148
+4K111312SanteviewSehyun Co., Ltd.20110—
+4K102123Vizion DRViztek, Inc.201136—
+4K103597DX-D 100Agfa Healthcare N.V.201116
+4K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+4K102012Digital RadiographyCanon Inc. -Medical Equipment Group2010801
+4K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+4K091752Viztek WLViztek, Inc.20090—
+4K082261Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd.20080—
+4K082798Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000Medicatech USA20080—
+5K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+5K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—
+5K242119Innovision-ExiiDk Medical System20252—
+5K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20242—
+5K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+5K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation20230—
+5K223842DRX - CompassCarestream Health, Inc.20231—
+5K221335D²RS and D²RS 9090Stephanix20220—
+5K220271Hand Diagnostic Radiography Imaging SystemNanoray Biotech Co., Ltd.20220—
+5K212940Skanmobile, Skanmobile-DrSkanray Technologies Limited20220—
+5K214012Straight Arm DDRKonica Minolta Healthcare Americas, Inc.20221—
+5K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+5K212269Intelligent NRCanon, Inc.20210—
+5K2109851717FCCRayence Co., Ltd.20210—
+5K202388Apolo D / Apolo SVmi Tecnologias Ltda20200—
+5K2027221212FCARayence Co., Ltd.20203—
+5K202293Radiographic System Challenge XSedecal., Sa.20200—
+5K2017961717SCV, 1717SGVRayence Co., Ltd.20200—
+5K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit.202003
+5K200787BSD3543WBontech Co., Ltd.20200—
+5K200887AS-10Canon, Inc.20200—
+5K193637MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20200—
+5K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation20196—
+5K191884DR 100sAgfa N.V.20190—
+5K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+5K182880Halifax Imaging KitHalifax Biomedical, Inc.20180—
+5K182647GC70Samsung Electronics Co., Ltd.20180—
+5K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+5K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH20183—
+5K181631GR40CWSamsung Electronics Co., Ltd.20185—
+5K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+5K173953uDR 780iShanghai United Imaging Healthcare Co., Ltd.20182—
+5K172681Edge Air Digital Flat Panel X-ray DetectorOsko, Inc.20171—
+5K172682Edge Digital Flat Panel X-ray DetectorOsko, Inc.20170—
+5K1714181417WCC_127um and1417WCC_140umRayence Co., Ltd.20172—
+5K1714171417WGC_127um and 1417WGC_140umRayence Co., Ltd.20170—
+5K170332Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessCanon, Inc.201715—
+5K162344Innolux RicInnolux Corporation20161—
+5K162552Evs 3643, Evs 3643GDRTECH Corporation20163—
+5K162504SKR 3000Konica Minolta, Inc.20168—
+5K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+5K152894Vivix-S 1717NVieworks Co., Ltd.20169—
+5K152855Vivix-S 1012NVieworks Co., Ltd.20165—
+5K150929CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.201512—
+5K151465AeroDR SYSTEM 2Konica Minolta, Inc.201521
+5K150816Jumong SeriesSg Healthcare Co, Ltd.20152—
+5K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+5K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemMedicatech USA20152—
+5K142184DX-D Imaging PackageAgfa Healthcare N.V.20142—
+5K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+5K141895Mobilediagnost WDRSedecal., Sa.201432
+5K141440Dicompacs DX-R with Flat PanelOehm Und Rehbein GmbH20142—
+5K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc.201412—
+5K141566Solid State X-Ray Imaging Device, Digiital Flat Panel X-Ray Detector, 1417WCCRayence Co., Ltd.20140—
+5K141563Solid State X-Ray Imaging Device, Digital Flat Panel X-Ray Detector, 1417WGCRayence Co., Ltd.20140—
+5K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+5K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+5K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+5K112661Vizion DRViztek, LLC201134—
+5K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc.201152—
+5K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc.201154—
+6K252503Intelligent NRCanon, Inc.20260—
+6K253446AeroDR TX c02Dk Medical Systems Co., Ltd.20260—
+6K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+6K250976Airbile-100Poskom Co., Ltd.20250—