510(k) Report

Devices descending from K981556

443 later devices reach Canon X-Ray Digital Camera Cxdi-11 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+4K102327Clearvision DR 7000FJpi Healthcare Co, Ltd.20120—
+4K120380Saturn 8000New Medical Co., Ltd.20120—
+4K113855Panorad, Panorad SLImix Adr Finland OY20120—
+4K113630Digital Flat Panel X-Ray Detector/1210SGARayence Co., Ltd.20111—
+4K112751SDX-4343CSSamsung Mobile Display Co., Ltd.20110—
+4K112558Digital Flat Panel X-Ray DetectorSamsung Mobile Display Co., Ltd.20110—
+4K112670DX-D 600Agfa Healthcare N.V.201174
+4K103348Digiview 250Kub Technologies, Inc.20110—
+4K111682Digital RadiographyCanon Inc. -Medical Equipment Group20113—
+4K112309Digital RadiographyCanon Inc. -Medical Equipment Group201122—
+4K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc.20110—
+4K111098Innovaxion FP, Innovaxion FP 1600 Plus, MagellanImaging Dynamics Company, Ltd.20110—
+4K102349Aerodr SystemKonica Minolta Medical & Graphic, Inc.201022—
+4K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+4K093790Simondr DRPSimondr, Inc.20100—
+4K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+4K091545Digital Radiography Cxdi-60CCanon, Inc.200982—
+4K091436Digital Radiography, Model Cxdi-55CCanon, Inc.200941
+4K090322Easy Moving Plus, SM-XXHF-YYSedecal., Sa.20095031
+4K090279Sedecal, Millennium PlusSedecal., Sa.200917—
+4K082604Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc.200841—
+4K082627Minxray, Model CMDR-1S and CMDR-1S-MilMinxray, Inc.200815—
+4K080582Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FAMedicatech USA200816—
+4K073650Fujifilm Unity Speedsuite, Model CR-IR 371Fujifilm Medical Systems U.S.A, Inc.20080—
+4K073114Imix Insight X-Ray SystemsImix Adr Finland OY20082—
+4K071193Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp.20074—
+4K063283Definium 5000 X-Ray SystemSedecal., Sa.2006143
+5K260482DRE DuoJpi Healthcare Co, Ltd.20260—
+5K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation20260—
+5K241980!M1Solutions For Tomorrow AB20251—
+5K244010ExamVue ApexJpi Healthcare Co, Ltd.20250—
+5K230800Xvision-525, Horizon, HI-300, HI-500, Saturn-F PF32, Saturn-F PF40, Saturn-F PF50Gemss Healthcare CO., LTD.20230—
+5K223060DigiX FDXAllengers Medical Systems Limited20224—
+5K213479D²RS and D²RS 9090Stephanix20211—
+5K203188ADDH&abyz Co., Ltd.20213—
+5K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsSedecal., Sa.20210—
+5K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20208—
+5K202156Diamond-5A/6A/8ADRGEM Corporation20201—
+5K201640DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd.202002
+5K201373DRX-CompassCarestream Health, Inc.202021
+5K200418Vivix-S VWVieworks Co., Ltd.20204—
+5K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System…Konica Minolta Healthcare Americas, Inc.20202—
+5K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation20190—
+5K191504PowerDRRadiology Information Systems, Inc.20190—
+5K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+5K182134ARiX RAD Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20181—
+5K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+5K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+5K173299Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa.20184—
+5K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+5K171270Digital Radiography Cxdi-410C WirelessCanon, Inc.20172—
+5K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+5K172581CareView 1800Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20170—
+5K1714191717SGC_127um and 1717SGC_140umRayence Co., Ltd.20171—
+5K1714201717SCC_127um and 1717SCC_140umRayence Co., Ltd.20173—
+5K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+5K171085GMR40Neurologica Corporation, A Subsidiary OF201701
+5K163703Vivix-S 1417NVieworks Co., Ltd.20175—
+5K163410DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd.201714
+5K162555Evs 4343, Evs 4343GDRTECH Corporation20167—
+5K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+5K162487BSD3543 Digital Flat Panel X-ray DetectorBontech, Inc.20161—
+5K1625181012WCC, 1012WGCRayence Co., Ltd.20164—
+5K1625191717WCC / 1717WGCRayence Co., Ltd.20162—
+5K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…Agfa Healthcare N.V.20161—
+5K162178CareView 1500P X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+5K153318Philips Eleva Workspot with SkyFlowPhilips Medical Systems Dmc GmbH20150—
+5K152639DR 600Agfa Healthcare N.V.20156—
+5K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20158—
+5K151942EVS 3643DRTECH Corporation20154—
+5K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+5K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+5K142718Radlink GPSRadlink, Inc.20141—
+5K141271Aerodr System 2Konica Minolta, Inc.201412—
+5K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH201466
+5K140646Digital Flat Panel X-Ray Detector / 1717G, XMARU1717GRayence Co., Ltd.20140—
+5K133782Nova FA DR SystemSedecal., Sa.2014111
+5K133409Digital Flat Panel X-Ray Detector/ 910SGARayence Co., Ltd.20140—
+5K131114Digital Flat Panel X-Ray DetectorRayence Co., Ltd.20132—
+5K130936Aerodr System with P-31Konica Minolta Medical & Graphic, Inc.201313—
+5K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…Canon, Inc.201321—
+5K130935Digital Flat Panel X-Ray Detector/1417WCARayence Co., Ltd.20134—
+5K123499AeropilotKonica Minolta Medical & Graphic, Inc.20120—
+5K122495Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc.201213—
+5K121345SR Suite 1.0Halifax Biomedical, Inc.20121—
+5K120477Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc.201214—
+5K113248Aerodr System with P-21Konica Minolta Medical & Graphic, Inc.201214—
+5K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+5K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa.2011164
+5K111725Mobilediagnost WDRSedecal., Sa.201148
+5K102123Vizion DRViztek, Inc.201136—
+5K102012Digital RadiographyCanon Inc. -Medical Equipment Group2010801
+5K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+5K091752Viztek WLViztek, Inc.20090—
+5K082261Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd.20080—
+5K082798Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000Medicatech USA20080—
+6K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+6K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+6K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—