510(k) Report

Devices descending from K901558

3 later devices reach Giotto Mammography HF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973856Giotto HTSitco, Inc.19972—
+2K012953Giotto ImageMedx, Inc.20011—
+3K111434Giotto Image 3D, Giotto Image 3D-LGiotto USA, LLC20110—