510(k) Report

Devices descending from K191200

3 later devices reach TULSA-PRO System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230692TULSA-PRO SystemProfound Medical, Inc.20230—
+1K211858TULSA-PRO SystemProfound Medical, Inc.20220—
+1K202286Tulsa-Pro SystemProfound Medical, Inc.20200—