510(k) Report

Devices descending from K180006

3 later devices reach AmCAD-UT Detection 2.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203555AmCAD-UTAmcad Biomed Corporation20212—
+2K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+3K250484PIUR tUS insidePiur Imaging GmbH20250—