510(k) Report

Devices descending from K181195

7 later devices reach ClearPoint System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222519ClearPoint SystemClearPoint Neuro, Inc.20222—
+1K200079ClearPoint System and AccessoriesMri Interventions, Inc.20203—
+2K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.20250—
+2K233243ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc.20231—
+2K202575ClearPoint Array SystemClearPoint Neuro, Inc.20212—
+3K232102ClearPoint Array System (Version 1.2)ClearPoint Neuro, Inc.20230—
+3K214040ClearPoint Array System (version 1.1)ClearPoint Neuro, Inc.20221—