510(k) Report

Devices descending from K170090

3 later devices reach RTHawk, HeartVista Cardiac Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183274RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20192—
+2K212233RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20211—
+3K251029Vista OS, Vista AI Scan, RTHawkVista AI, Inc.20250—