510(k) Report

Devices descending from K200726

9 later devices reach AcuityPDR through their predicates, nearest generation first.

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