510(k) Report

Devices descending from K020436

25 later devices reach Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103522SedecalSedecal., Sa.20117—
+1K042361Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc.200422—
+2K222258Combined High Frequency X-ray SourceSuzhou Powersite Electric Co., Ltd.20220—
+2K121410Dragon LWSedecal., Sa.20125—
+2K082627Minxray, Model CMDR-1S and CMDR-1S-MilMinxray, Inc.200815—
+3K173299Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa.20184—
+3K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+4K212940Skanmobile, Skanmobile-DrSkanray Technologies Limited20220—
+4K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH20183—
+4K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+5K250976Airbile-100Poskom Co., Ltd.20250—
+5K183388JADE Mobile X-RayDRGEM Corporation20190—
+5K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+6K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+7K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+7K200726AcuityPDRRadmedix, LLC20209—
+8K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+8K201058Accuvue+Radmedix, LLC20204—
+9K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+9K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+9K210919AcuityDReRadmedix, LLC20213—
+10K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+10K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+11K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—