510(k) Report

Devices descending from DEN210003

2 later devices reach SureTune4 Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243520Bullsai ConfirmTuring Medical Technologies, Inc.20250—
+1K213930Brainlab Elements Guide XT, Guide 3.0Brainlab AG20220—