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
+5K183388JADE Mobile X-RayDRGEM Corporation20190—
+5K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+5K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+5K181003Vivix-S 1717VVieworks Co., Ltd.20187—
+5K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+5K173187MobileDiagnost M50Philips India Limited20170—
+5K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+5K172581CareView 1800Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20170—
+5K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+5K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+5K162529DigiX FDXAllengers Medical Systems Limited20176—
+5K170332Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C WirelessCanon, Inc.201715—
+5K163703Vivix-S 1417NVieworks Co., Ltd.20175—
+5K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+5K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+5K162687Paragon 2Meridian Medical Systems, LLC20160—
+5K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…Agfa Healthcare N.V.20161—
+5K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorPerkinelmer, Inc.20161—
+5K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel DetectorPerkinelmer, Inc.20160—
+5K162178CareView 1500P X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20160—
+5K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.20158—
+5K151219Models 2200DR and 1600DR Digital Stationary Radiographic SystemsBeijing Polycon Medical Engineering Company20150—
+5K151221Kubtec DIGIVIEW 395Kub Technologies, Inc.20150—
+5K142718Radlink GPSRadlink, Inc.20141—
+5K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.20147—
+5K140825Delworks DR SystemDel Medical, Inc.20147—
+5K133693Digital Radiography Cxdi-401C WirelessCanon, Inc.20146—
+5K133139Vizion UltraViztek, LLC20140—
+5K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.201350—
+5K123644Vizion + DRViztek, LLC201333—
+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—
+6K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB20250—
+6K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.20250—
+6K250790Innovision-DxiiDk Medical Systems Co., Ltd.20250—
+6K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation20250—
+6K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation20250—
+6K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+6K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20241—
+6K242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)Rayence Co., Ltd.20240—
+6K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+6K2403710909FCC, 0909FCC-HSRayence Co., Ltd.20241—
+6K233678Radiography 7000 MPhilips Medical Systems Dmc GmbH202401
+6K232082EXPD 4343SDRTECH Corporation20240—
+6K231959Expd 4357; Expd 4357PDRTECH Corporation20230—
+6K222353GM85Samsung Electronics Co., Ltd.202223
+6K220239Solid State X-ray Imager (Model: FXRD-4386WB)Vieworks Co., Ltd.20221—
+6K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd.20222—
+6K220510Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20225—
+6K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1Canon, Inc.20222—
+6K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+6K212515MOVIX DReamyStephanix20210—
+6K212291PhoenixSedecal., Sa.202141
+6K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1Canon, Inc.20213—
+6K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+6K211790DX-D Imaging Package with XD DetectorsAgfa N.V.20210—
+6K203703I-Q ViewFirst Source, Inc.20210—
+6K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+6K192936Soltus 500Sedecal., Sa.201901
+6K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessCanon, Inc.20193—
+6K192541DigiX FDXAllengers Medical Systems Limited20195—
+6K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+6K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation20180—
+6K173517RADspeed fitShimadzu Corporation20181—
+6K171270Digital Radiography Cxdi-410C WirelessCanon, Inc.20172—
+6K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd.20171—
+6K171119GM85Samsung Electronics Co., Ltd.2017221
+6K170975Televere Digital Imaging SystemTelevere Systems20172—
+6K153492CareView 1800LCareray Digital Medical System Co., Ltd.20155—
+6K152279ViZion DR + WirelessViztek, LLC201527—
+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—
+6K141435Opal Chiro, 20/20 P-DR2020 Imaging20140—
+7K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…DRTECH Corporation20260—
+7K2538000909FCE, 0909FCE-HSRayence Co., Ltd.20260—
+7K260820Vivix-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.20260—
+7K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20250—
+7K243171Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20241—
+7K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+7K240771PRORAD X-Ray Flat Panel Detector with DROCPrognosys Medical Systems Private Limited20240—
+7K242651GM85Samsung Electronics Co., Ltd.20240—
+7K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+7K232185SM-IVSedecal., Sa.20230—
+7K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+7K223009Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20221—
+7K222951SM-VSedecal., Sa.20221—
+7K223060DigiX FDXAllengers Medical Systems Limited20224—
+7K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+7K221620Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc.20221—
+7K220518Skanrad 400Skanray Technologies Limited20220—
+7K220098Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20222—
+7K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+7K203849General Radiography CXDI-CS01Canon, Inc.20212—
+7K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+7K200726AcuityPDRRadmedix, LLC20209—
+7K200668DR-ID 1200SDK SystemFujifilm Corporation20200—
+7K193173CareView 1800LeCareray Digital Medical System Co., Ltd.20194—
+7K192932FDR D-EVO III flat panel detector systemFujifilm Corporation20190—
+7K192440FDR SE LiteFujifilm Corporation20190—