510(k) Report

Devices descending from K211541

3 later devices reach MammoScreen 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240301MammoScreen® (3)Therapixel20242—
+2K243679MammoScreen® (4)Therapixel20251—
+3K260714MammoScreen® (5)Therapixel20260—