510(k) Report

Devices descending from K141885

13 later devices reach CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.201712—
+2K191451CMDR 2CW (Multiple models)Minxray, Inc.201911—
+3K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+3K200726AcuityPDRRadmedix, LLC20209—
+4K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+4K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+4K201058Accuvue+Radmedix, LLC20204—
+5K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+5K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+5K210919AcuityDReRadmedix, LLC20213—
+6K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+6K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+7K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—