510(k) Report

Devices descending from K102556

24 later devices reach Volpara, Version 1.3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152009DENSEEMAMMO v1.0Statlife20161—
+1K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+1K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+1K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+1K132742M-VU Breast DensityVucomp, Inc.201311—
+1K120472QuantraHologic, Inc.20123—
+2K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+2K173574DenSeeMammoStatlife20180—
+2K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+2K170540DM-DensityDensitas, Inc.20187—
+2K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+2K142037QuantraHologic, Inc.20141—
+3K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+3K203785ClariSIGMAMClaripi, Inc.20210—
+3K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+3K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+3K201411Visage Breast DensityVisage Imaging GmbH20210—
+3K192973densitas densityaiDensitas, Inc.20205—
+3K163623QuantraHologic, Inc.20170—
+4K222275Saige-DensityDeepHealth, Inc.20221—
+4K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+5K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+5K241561MammoScreen BDTherapixel20241—
+6K243685MammoScreen BDTherapixel20250—