510(k) Report

Devices descending from K213529

3 later devices reach Focus HD 43 Detector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited20252—
+2K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+2K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited20250—