510(k) Report

Devices descending from K152028

8 later devices reach Volpara Imaging Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+1K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+1K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+2K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+2K201411Visage Breast DensityVisage Imaging GmbH20210—
+2K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+3K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+3K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—