510(k) Report

Devices descending from K153247

4 later devices reach Fusion Compact Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Medtronic Navigation, Inc.20202—
+1K170018StealthStationTM S8 ENT SoftwareMedtronic Navigation, Inc.20173—
+2K253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.20260—
+2K223734ENT EMBrainlab AG20230—