510(k) Report

Devices descending from K070618

78 later devices reach Dicompacs, Model 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113855Panorad, Panorad SLImix Adr Finland OY20120—
+1K103554Metron-CP/MDEponatech, LLC20110—
+1K110040OmnivisionModern Module, Inc.201115—
+1K101435Imix Panorad and SomaradImix Adr Finland OY20101—
+1K091364Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH200958—
+2K150725Visaris AvanseVisaris D.O.O. Belgrade20151—
+2K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA201114—
+2K110033Feel-DRCSImfou Co., Ltd.201116—
+2K102078Radiological Image Processing SystemVATECH Co., Ltd.20116—
+2K101517Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa.2011164
+2K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+3K231225EConsole1DRTECH Corporation20233—
+3K161937CuattroDRCuattro, LLC201601
+3K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa.20161413
+3K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd.20165—
+3K152172Econsole1DRTECH Corporation20156—
+3K142930Exam Vue DRJpi Healthcare Co, Ltd.20151—
+3K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+3K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG20130—
+3K130377Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMedicatech USA20131—
+3K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa.201311—
+3K123650Arix Rad Acquisition ConsoleCompania Mexicana DE Radiologia Cgr, S.A. DE C.V.20132—
+4K251410VXvueVieworks Co., Ltd.20250—
+4K251038Digital Radiographic Imaging Acquisition Software - DR (RiasDR)Shen Zhen Cambridge-Hit Co., Ltd.20250—
+4K241425AspenViewAspen Imaging Healthcare, Inc.20250—
+4K240243EConsole2DRTECH Corporation20240—
+4K230918MasterX 800 SeriesMedicatech USA20230—
+4K213057ExamVue DuoJpi Healthcare Co, Ltd.20220—
+4K211542Primo SA.T.S. Applicazione Tecnologie Speciali S.R.L.20210—
+4K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda20201—
+4K193644E-Com DR-2000 DRLivermoretech, Inc.20201—
+4K192011PhoeniXSedecal., Sa.20198—
+4K191188ASHK100GLg Electronics20192—
+4K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)Rayence Co., Ltd.20190—
+4K182537RADMAX Digital Imaging SoftwareDRGEM Corporation20190—
+4K183478ClearON MobileRayence Co., Ltd.20190—
+4K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation20181—
+4K173018MDR17 Mobile Direct Radiographic SystemDel Medical, Inc.20170—
+4K170729Examion X-AQSExamion GmbH20170—
+4K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K162670RSM 1824C with RConsole1DRTECH Corporation20174—
+4K162687Paragon 2Meridian Medical Systems, LLC20160—
+4K140825Delworks DR SystemDel Medical, Inc.20147—
+5K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…Shenzhen Browiner Tech Co., Ltd.20240—
+5K212137X-CleverLg Electronics.Inc20211—
+5K212515MOVIX DReamyStephanix20210—
+5K212291PhoenixSedecal., Sa.202141
+5K212134Diagnostic X-ray System/PLX5200ANanjing Perlove Medical Equipment Co., Ltd.20210—
+5K2029022430MCA with Xmaru WRayence Co., Ltd.20211—
+5K203703I-Q ViewFirst Source, Inc.20210—
+5K192936Soltus 500Sedecal., Sa.201901
+5K192541DigiX FDXAllengers Medical Systems Limited20195—
+5K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+5K170930RSM 2430CDRTECH Corporation20171—
+6K2438492430TCA with Xmaru WRayence Co., Ltd.20250—
+6K241113Vivix-MVieworks Co., Ltd.20250—
+6K233599X-Clever (ASHK100G)Lg Electronics.Inc20240—
+6K232185SM-IVSedecal., Sa.20230—
+6K222951SM-VSedecal., Sa.20221—
+6K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+6K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+6K200726AcuityPDRRadmedix, LLC20209—
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K231577MOBILETT ImpactSiemens Medical Solutions20230—
+7K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+7K201058Accuvue+Radmedix, LLC20204—
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+8K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+8K210919AcuityDReRadmedix, LLC20213—
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+9K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+9K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+10K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—