510(k) Report

Devices descending from K153023

7 later devices reach Ablatherm Integrated Imaging through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191200TULSA-PRO SystemProfound Medical, Inc.20193—
+1K172721Focal OneEdap Technomed, Inc.20181—
+1K172285Ablatherm FusionEdap Technomed, Inc.20170—
+2K251910Focal One®Edap Technomed, Inc.20250—
+2K230692TULSA-PRO SystemProfound Medical, Inc.20230—
+2K211858TULSA-PRO SystemProfound Medical, Inc.20220—
+2K202286Tulsa-Pro SystemProfound Medical, Inc.20200—