510(k) Report

Devices descending from K042361

22 later devices reach Digital Portable X-Ray Units, Model SP-HF-4.0 D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121410Dragon LWSedecal., Sa.20125—
+1K082627Minxray, Model CMDR-1S and CMDR-1S-MilMinxray, Inc.200815—
+2K173299Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa.20184—
+2K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+3K212940Skanmobile, Skanmobile-DrSkanray Technologies Limited20220—
+3K182317AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH20183—
+3K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+4K250976Airbile-100Poskom Co., Ltd.20250—
+4K183388JADE Mobile X-RayDRGEM Corporation20190—
+4K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+5K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+6K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+6K200726AcuityPDRRadmedix, LLC20209—
+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—
+8K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+8K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+8K210919AcuityDReRadmedix, LLC20213—
+9K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+9K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+10K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—