Regulatory evidence record · Viz.ai
Viz Subdural+
Locked AI/ML analysis of non-contrast head CT for labeling and quantifying subdural collections, maximum width, and midline shift.
Original dossier: FDA 510(k) K250354 · Jun 10, 2025
Anonymous editorial source review; independent professional peer review is not claimed. Page updates do not reset evidence dates.
What the cited dossier supports
Retrospective two-site testing used 203 cases for subdural collection measurements and 151 for midline shift; reported mean absolute errors were 7.53 mL, 1.77 mm, and 1.1 mm respectively.
Clinical boundary
The output covers a single CT time point and must be reviewed with the original images by a qualified physician.
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, two-site retrospective sample sizes and measurement errors were confirmed. These are standalone measurement results, not evidence that using the tool improves recovery or determines the need for surgery. Labeling covers a single CT time point and requires review of the original images.
FDA database record K250354 · Decision Jun 10, 2025.
Source locations: FDA PDF pp. 4, 6, 10–11 (summary pp. 2, 6–7).
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.