510(k) Report

Devices descending from K212150

1 later device reach Exablate Prostate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231378Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0Insightec, Ltd.20230—