510(k) Report

Devices descending from K132742

11 later devices reach M-VU Breast Density through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+1K170540DM-DensityDensitas, Inc.20187—
+2K203785ClariSIGMAMClaripi, Inc.20210—
+2K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+2K201411Visage Breast DensityVisage Imaging GmbH20210—
+2K192973densitas densityaiDensitas, Inc.20205—
+3K222275Saige-DensityDeepHealth, Inc.20221—
+3K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+4K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+4K241561MammoScreen BDTherapixel20241—
+5K243685MammoScreen BDTherapixel20250—