510(k) Report

Devices descending from K221449

2 later devices reach Genius AI Detection 2.0 through their predicates, nearest generation first.

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