510(k) Report

Devices descending from K990192

3 later devices reach Biopsy-Digit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062039Biopsy Digit-AMGiotto USA, LLC20062—
+2K113607Biopsy Digit S Biopsy SLGiotto USA, LLC20121—
+3K163388XPress BCD Breast Compression DeviceXpress Bcd, LLC20170—