510(k) Report

Devices descending from K031633

156 later devices reach Canon Inc., Digital Radiography, Model Cxdi-40C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa.200946—
+1K082347Digital Radiography, Flexdr C30Konica Minolta Technoproduct Co., Ltd.200823—
+1K062221Cxdi-40ECCanon, Inc.200625—
+1K060433Digital Radiography Cxdi-50CCanon, Inc.2006136—
+2K150506ELIAN Digital Diagnostic X-ray SystemOsko, Inc.20150—
+2K132294Galaxy and Galaxy+Plus Digital Radiography SystemsRadiology Solutions, LLC20131—
+2K103591Digital RadiographyCanon Inc. -Medical Equipment Group201124—
+2K102408Digital Diagnostic X-Ray SystemDRGEM Corporation201017—
+2K102349Aerodr SystemKonica Minolta Medical & Graphic, Inc.201022—
+2K092830Digital X-Ray Imaging System, Model DRC-1000VATECH Co., Ltd.201018—
+2K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+2K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+2K091545Digital Radiography Cxdi-60CCanon, Inc.200982—
+2K091436Digital Radiography, Model Cxdi-55CCanon, Inc.200941
+3K203188ADDH&abyz Co., Ltd.20213—
+3K192453Diamond-5A/6A/8ADRGEM Corporation20192—
+3K192364GXR-Series Diagnostic X-Ray SystemDRGEM Corporation201911—
+3K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+3K153312Scatter Correction for Cxdi SeriesCanon, Inc.20162—
+3K141743Fusion Digital Diagnostic X-Ray Upgrade KitRadiology Solutions, LLC20140—
+3K141271Aerodr System 2Konica Minolta, Inc.201412—
+3K133693Digital Radiography Cxdi-401C WirelessCanon, Inc.20146—
+3K132921Galaxy PlusMedien International Co, Ltd.20140—
+3K130936Aerodr System with P-31Konica Minolta Medical & Graphic, Inc.201313—
+3K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+3K123499AeropilotKonica Minolta Medical & Graphic, Inc.20120—
+3K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+3K120477Aerosync for Aerodr SystemKonica Minolta Medical & Graphic, Inc.201214—
+3K113855Panorad, Panorad SLImix Adr Finland OY20120—
+3K113248Aerodr System with P-21Konica Minolta Medical & Graphic, Inc.201214—
+3K111682Digital RadiographyCanon Inc. -Medical Equipment Group20113—
+3K112309Digital RadiographyCanon Inc. -Medical Equipment Group201122—
+3K111312SanteviewSehyun Co., Ltd.20110—
+3K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+3K102012Digital RadiographyCanon Inc. -Medical Equipment Group2010801
+3K091090Digital Flat Panel X-Ray Detector, Model Xmaru 1717E-Woo Technology201017—
+4K260482DRE DuoJpi Healthcare Co, Ltd.20260—
+4K241980!M1Solutions For Tomorrow AB20251—
+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—
+4K213479D²RS and D²RS 9090Stephanix20211—
+4K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+4K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20208—
+4K202156Diamond-5A/6A/8ADRGEM Corporation20201—
+4K200887AS-10Canon, Inc.20200—
+4K190368Enhanced Feature Software Pack CXDI SeriesCanon, Inc.20191—
+4K171270Digital Radiography Cxdi-410C WirelessCanon, Inc.20172—
+4K162504SKR 3000Konica Minolta, Inc.20168—
+4K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+4K151465AeroDR SYSTEM 2Konica Minolta, Inc.201521
+4K142475EVS 4343DRTECH Corporation201513—
+4K131106Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital…Canon, Inc.201321—
+4K122173Digital Flat Planel X-Ray Detector / 1717SCCRayence Co., Ltd.20120—
+4K122182Digital Flat Panel X-Ray Detector/1717SGCRayence Co., Ltd.20121—
+4K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc.201152—
+4K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc.201154—
+5K252503Intelligent NRCanon, Inc.20260—
+5K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+5K250665SKR 3000Konica Minolta, Inc.20250—
+5K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—
+5K242119Innovision-ExiiDk Medical System20252—
+5K241319SKR 3000Konica Minolta, Inc.20241—
+5K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20242—
+5K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation20230—
+5K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+5K221335D²RS and D²RS 9090Stephanix20220—
+5K220271Hand Diagnostic Radiography Imaging SystemNanoray Biotech Co., Ltd.20220—
+5K212269Intelligent NRCanon, Inc.20210—
+5K172793SKR 3000Konica Minolta, Inc.20175—
+5K170332Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessCanon, Inc.201715—
+5K162555Evs 4343, Evs 4343GDRTECH Corporation20167—
+5K151942EVS 3643DRTECH Corporation20154—
+5K140646Digital Flat Panel X-Ray Detector / 1717G, XMARU1717GRayence Co., Ltd.20140—
+5K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201350—
+5K120629FDR GO FlexFujifilm Medical System U.S.A., Inc.20120—
+5K111865Wired/ Wireless FDR D-Evo with X-Ray Detection FeatureFujifilm Medical System U.S.A., Inc.20110—
+6K253446AeroDR TX c02Dk Medical Systems Co., Ltd.20260—
+6K250790Innovision-DxiiDk Medical Systems Co., Ltd.20250—
+6K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+6K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20241—
+6K220510Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20225—
+6K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1Canon, Inc.20222—
+6K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc.20213—
+6K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessCanon, Inc.20193—
+6K192400Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AGDRTECH Corporation20196—
+6K182688SKR 3000Konica Minolta, Inc.20184—
+6K173517RADspeed fitShimadzu Corporation20181—
+6K162552Evs 3643, Evs 3643GDRTECH Corporation20163—
+6K142003FDR D-Evo II Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.201416—
+6K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201432—
+7K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…DRTECH Corporation20260—
+7K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20250—
+7K243171Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20241—
+7K240771PRORAD X-Ray Flat Panel Detector with DROCPrognosys Medical Systems Private Limited20240—
+7K232753Expd 4343D; Expd 3643DDRTECH Corporation20230—
+7K223009Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20221—
+7K223124Expd 86P, Expd 86PG, Expd 129P, Expd 129PGDRTECH Corporation20222—
+7K221620Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20221—
+7K220518Skanrad 400Skanray Technologies Limited20220—
+7K220098Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20222—