510(k) Report

Devices descending from K170540

7 later devices reach DM-Density through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203785ClariSIGMAMClaripi, Inc.20210—
+1K192973densitas densityaiDensitas, Inc.20205—
+2K222275Saige-DensityDeepHealth, Inc.20221—
+2K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+3K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+3K241561MammoScreen BDTherapixel20241—
+4K243685MammoScreen BDTherapixel20250—