510(k) Report

Devices descending from K201019

3 later devices reach Genius AI Detection through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221449Genius AI Detection 2.0Hologic, Inc.20222—
+2K243341Genius AI Detection 2.0Hologic, Inc.20250—
+2K230096Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc.20230—