510(k) Report

Devices descending from K050196

36 later devices reach Sectra IDS5 Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120472QuantraHologic, Inc.20123—
+1K082483QuantraHologic, Inc.200825—
+1K051315Modification to: Sectra IDS5 WorkstationSectra Imtec AB2005351
+2K142037QuantraHologic, Inc.20141—
+2K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+2K132742M-VU Breast DensityVucomp, Inc.201311—
+2K102556Volpara, Version 1.3Matakina Technology Limited201024—
+2K063093Sectra Workstation, Version 11.1Sectra Imtec AB2006341
+3K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+3K170540DM-DensityDensitas, Inc.20187—
+3K163623QuantraHologic, Inc.20170—
+3K152009DENSEEMAMMO v1.0Statlife20161—
+3K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+3K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+3K081630Mammo WorkstationImage Diagnost International GmbH20084—
+3K081469Sectra Workstation, IDS7 Version 11.3, IDS5 Version 11.1 P2Sectra Imtec AB20080—
+3K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+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—
+4K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+4K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+4K123575MammoworkstationImage Diagnost International GmbH20132—
+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—
+5K143361Mammo WorkstationGE Healthcare20151—
+6K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+6K241561MammoScreen BDTherapixel20241—
+6K160937SenolrisGE Healthcare20160—
+7K243685MammoScreen BDTherapixel20250—