Medtronic Navigation, Inc.

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Medtronic Navigation, Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2026-03-26	K253379	Stealth AXiS Cranial clinical application	Medtronic Navigation, Inc.	Neurology
2026-02-12	K253381	Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application	Medtronic Navigation, Inc.	Neurology
2024-06-21	K240465	O-arm O2 Imaging System	Medtronic Navigation, Inc	Radiology

All companies