510(k) Report

Devices descending from K082627

15 later devices reach Minxray, Model CMDR-1S and CMDR-1S-Mil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100449Minxray Model CMDR-2SMinxray, Inc.201014—
+2K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc.201413—
+3K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+4K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+5K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+5K200726AcuityPDRRadmedix, LLC20209—
+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—