510(k) Report

Devices descending from K210919

3 later devices reach AcuityDRe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+1K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+2K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—