510(k) Report

Devices descending from K182373

7 later devices reach PowerLook Tomo Detection V2 Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201019Genius AI DetectionHologic, Inc.20203—
+1K191994ProFound AI Software V2.1Icad, Inc.20192—
+2K221449Genius AI Detection 2.0Hologic, Inc.20222—
+2K203822ProFound AI Software V3.0Icad, Inc.20211—
+3K243341Genius AI Detection 2.0Hologic, Inc.20250—
+3K240417ProFound Detection (V4.0)Icad, Inc.20240—
+3K230096Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc.20230—