Regulatory evidence record · Medtronic Navigation
Stealth AXiS Cranial clinical application
Cranial planning and stereotactic navigation for tumor resection, catheter placement, electrodes, leads, probes, and biopsy; the dossier describes automatic image merging and generated tractography.
Original dossier: FDA 510(k) K253379 · Mar 26, 2026
Anonymous editorial source review; independent professional peer review is not claimed. Page updates do not reset evidence dates.
What the cited dossier supports
Software verification and nonclinical accuracy testing; the public summary reports worst-case mean error at or below 2 mm and 2°.
Clinical boundary
The public file does not establish better patient outcomes or superiority to other navigation systems.
Inclusion is not endorsement; clearance does not establish superior clinical outcomes.
Sources and check history
Sources checked Sep 6, 2026; this is the evidence-search date, not the page-update date.
Source check · Sep 6, 2026
The cited clearance, indications and nonclinical accuracy values were confirmed. The dossier states that no clinical testing was performed. Autotracts outputs require user verification; navigation accuracy is not a tractography accuracy metric.
FDA database record K253379 · Decision Mar 26, 2026.
Source locations: FDA PDF pp. 4, 9–10 (summary pp. 5–6 for testing and AI).
No matching recall was returned by the identifier query. Recall queries used the listed 510(k) identifiers and product/manufacturer names. The retrieved openFDA recall dataset was last updated September 3, 2026. A missing match does not establish that a device is free of recalls, adverse events, or risk; reporting and indexing can lag.
No product-matched patient-outcome study published August 17–September 6, 2026 was verified in this targeted search. This is a search result, not proof that no new evidence exists. Older or differently named systems and company announcements were not treated as evidence of benefit for the listed version.
Targeted check of FDA decision records, cited summary sections, device-linked recall records, and indexed clinical literature. This is not a systematic review or continuous safety surveillance. Next planned safety scan: Oct 6, 2026. This check does not reset the original summary-review date.
Original FDA decision and summary (PDF)
Original summary reviewed Aug 17, 2026 · Next scheduled full regulatory review Nov 17, 2026.
Index inclusion and evidence methodology
Editorial responsibility: Neurosurgery.ai (anonymous site-name attribution). Editorial policy.