510(k) Report

Devices descending from K051315

35 later devices reach Modification to: Sectra IDS5 Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063093Sectra Workstation, Version 11.1Sectra Imtec AB2006341
+2K081630Mammo WorkstationImage Diagnost International GmbH20084—
+2K081469Sectra Workstation, IDS7 Version 11.3, IDS5 Version 11.1 P2Sectra Imtec AB20080—
+2K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+3K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+3K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+3K123575MammoworkstationImage Diagnost International GmbH20132—
+3K082483QuantraHologic, Inc.200825—
+4K143361Mammo WorkstationGE Healthcare20151—
+4K132742M-VU Breast DensityVucomp, Inc.201311—
+4K120472QuantraHologic, Inc.20123—
+4K102556Volpara, Version 1.3Matakina Technology Limited201024—
+5K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+5K170540DM-DensityDensitas, Inc.20187—
+5K152009DENSEEMAMMO v1.0Statlife20161—
+5K160937SenolrisGE Healthcare20160—
+5K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+5K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+5K142037QuantraHologic, Inc.20141—
+5K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+6K203785ClariSIGMAMClaripi, Inc.20210—
+6K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+6K201411Visage Breast DensityVisage Imaging GmbH20210—
+6K192973densitas densityaiDensitas, Inc.20205—
+6K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+6K173574DenSeeMammoStatlife20180—
+6K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+6K163623QuantraHologic, Inc.20170—
+7K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+7K222275Saige-DensityDeepHealth, Inc.20221—
+7K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+7K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+8K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+8K241561MammoScreen BDTherapixel20241—
+9K243685MammoScreen BDTherapixel20250—