510(k) Report

Devices descending from K163253

4 later devices reach Arterys Cardio DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182034Arterys MICAArterys, Inc.20183—
+2K192437Arterys MICAArterys, Inc.20202—
+3K203744Arterys MICAArterys, Inc.20221—
+4K252539Tempus PixelArterys, Inc.20250—