510(k) Report

Devices descending from K062039

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

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