510(k) Report

Devices descending from K191994

2 later devices reach ProFound AI Software V2.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203822ProFound AI Software V3.0Icad, Inc.20211—
+2K240417ProFound Detection (V4.0)Icad, Inc.20240—