510(k) Report

Devices descending from K012719

13 later devices reach Navigus II MR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100836Clearpoint SystemSurgivision, Inc.201012—
+2K111073Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc.201111—
+3K142505ClearPoint SystemMri Interventions, Inc.201510—
+4K160434ClearPoint SystemMri Interventions, Inc.20169—
+5K171257ClearPoint SystemMri Interventions, Inc.20178—
+6K181195ClearPoint SystemMri Interventions, Inc.20187—
+7K222519ClearPoint SystemClearPoint Neuro, Inc.20222—
+7K200079ClearPoint System and AccessoriesMri Interventions, Inc.20203—
+8K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.20250—
+8K233243ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc.20231—
+8K202575ClearPoint Array SystemClearPoint Neuro, Inc.20212—
+9K232102ClearPoint Array System (Version 1.2)ClearPoint Neuro, Inc.20230—
+9K214040ClearPoint Array System (version 1.1)ClearPoint Neuro, Inc.20221—