Regulatory evidence record · Brainlab
RT Elements 4.5
Cranial and spine stereotactic radiotherapy planning, including AI cranial-tumor segmentation, multiple-brain-metastasis planning, retreatment review, and Spine SRS.
Original dossier: FDA 510(k) K250440 · Jun 17, 2025
Anonymous editorial source review; independent professional peer review is not claimed. Page updates do not reset evidence dates.
What the cited dossier supports
The dossier documents software verification, dose calculations, phantom comparisons, and algorithm-performance testing.
Clinical boundary
The submission reports no summative usability evaluation for version 4.5 and does not establish improved survival, control, or toxicity outcomes.
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, intended use, performance categories and absence of a summative usability evaluation for version 4.5 were confirmed. The 2019 RT Elements notice found in the name search lists older application versions; it was not assigned to version 4.5 without a matching affected-version record.
FDA database record K250440 · Decision Jun 17, 2025.
Source locations: FDA PDF pp. 5–6, 13–16 (summary pp. 1–2, 9–12).
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.