510(k) Report

Devices descending from K081630

4 later devices reach Mammo Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+1K123575MammoworkstationImage Diagnost International GmbH20132—
+2K143361Mammo WorkstationGE Healthcare20151—
+3K160937SenolrisGE Healthcare20160—