510(k) Report

Devices descending from K091364

58 later devices reach Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150725Visaris AvanseVisaris D.O.O. Belgrade20151—
+1K110033Feel-DRCSImfou Co., Ltd.201116—
+1K102078Radiological Image Processing SystemVATECH Co., Ltd.20116—
+1K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa.2011164
+1K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+2K231225EConsole1DRTECH Corporation20233—
+2K161937CuattroDRCuattro, LLC201601
+2K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+2K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd.20165—
+2K152172Econsole1DRTECH Corporation20156—
+2K142930Exam Vue DRJpi Healthcare Co, Ltd.20151—
+2K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+2K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+2K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20132—
+3K251410VXvueVieworks Co., Ltd.20250—
+3K251038Digital Radiographic Imaging Acquisition Software - DR (RiasDR)Shen Zhen Cambridge-Hit Co., Ltd.20250—
+3K241425AspenViewAspen Imaging Healthcare, Inc.20250—
+3K240243EConsole2DRTECH Corporation20240—
+3K213057ExamVue DuoJpi Healthcare Co, Ltd.20220—
+3K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda20201—
+3K192011PhoeniXSedecal., Sa.20198—
+3K191188ASHK100GLg Electronics20192—
+3K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)Rayence Co., Ltd.20190—
+3K182537RADMAX Digital Imaging SoftwareDRGEM Corporation20190—
+3K183478ClearON MobileRayence Co., Ltd.20190—
+3K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+3K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+3K170729Examion X-AQSExamion GmbH20170—
+3K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+3K162670RSM 1824C with RConsole1DRTECH Corporation20174—
+3K162687Paragon 2Meridian Medical Systems, LLC20160—
+4K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+4K212137X-CleverLg Electronics.Inc20211—
+4K212515MOVIX DReamyStephanix20210—
+4K212291PhoenixSedecal., Sa.202141
+4K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+4K2029022430MCA with Xmaru WRayence Co., Ltd.20211—
+4K192936Soltus 500Sedecal., Sa.201901
+4K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+4K170930RSM 2430CDRTECH Corporation20171—
+5K2438492430TCA with Xmaru WRayence Co., Ltd.20250—
+5K241113Vivix-MVieworks Co., Ltd.20250—
+5K233599X-Clever (ASHK100G)Lg Electronics.Inc20240—
+5K232185SM-IVSedecal., Sa.20230—
+5K222951SM-VSedecal., Sa.20221—
+5K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+5K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+5K200726AcuityPDRRadmedix, LLC20209—
+6K231577MOBILETT ImpactSiemens Medical Solutions20230—
+6K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+6K201058Accuvue+Radmedix, LLC20204—
+7K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+7K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+7K210919AcuityDReRadmedix, LLC20213—
+8K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+8K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+9K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—