510(k) Report

Devices descending from K073272

27 later devices reach Workstationone Breast Imaging Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+1K082483QuantraHologic, Inc.200825—
+2K132742M-VU Breast DensityVucomp, Inc.201311—
+2K120472QuantraHologic, Inc.20123—
+2K102556Volpara, Version 1.3Matakina Technology Limited201024—
+3K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+3K170540DM-DensityDensitas, Inc.20187—
+3K152009DENSEEMAMMO v1.0Statlife20161—
+3K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+3K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+3K142037QuantraHologic, Inc.20141—
+3K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+4K203785ClariSIGMAMClaripi, Inc.20210—
+4K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+4K201411Visage Breast DensityVisage Imaging GmbH20210—
+4K192973densitas densityaiDensitas, Inc.20205—
+4K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+4K173574DenSeeMammoStatlife20180—
+4K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+4K163623QuantraHologic, Inc.20170—
+5K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+5K222275Saige-DensityDeepHealth, Inc.20221—
+5K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+5K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+6K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+6K241561MammoScreen BDTherapixel20241—
+7K243685MammoScreen BDTherapixel20250—