510(k) Report

Devices descending from K191451

11 later devices reach CMDR 2CW (Multiple models) through their predicates, nearest generation first.

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