510(k) Report

Devices descending from K160942

5 later devices reach Sonablate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212150Exablate Prostate SystemInsightec, Inc.20211—
+1K172721Focal OneEdap Technomed, Inc.20181—
+1K172285Ablatherm FusionEdap Technomed, Inc.20170—
+2K251910Focal One®Edap Technomed, Inc.20250—
+2K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0Insightec, Ltd.20230—