Regulatory evidence record · Sora Neuroscience
Cirrus Resting State fMRI Software
A nonadaptive machine-learning pipeline that generates patient-specific motor, language, and vision resting-state fMRI correlation maps.
Original dossier: FDA 510(k) K251009 · Jun 6, 2025
Anonymous editorial source review; independent professional peer review is not claimed. Page updates do not reset evidence dates.
What the cited dossier supports
Validation included brain-tumor and epilepsy datasets; reported spatial correlations were 0.826 for sensorimotor and 0.793 for language maps, with vision-map AUC 0.84.
Clinical boundary
FDA labeling states that resting-state maps are adjunctive and do not replace direct functional mapping procedures.
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 and values were confirmed. Correlations of 0.826 and 0.793 compare Cirrus maps with resting-state maps evaluated in prior literature; they are not direct stimulation sensitivity estimates. Vision-map AUC 0.84 was assessed in 26 subjects. Labeling notes repeat-scan variability and states that these maps do not replace direct functional mapping.
FDA database record K251009 · Decision Jun 6, 2025.
Source locations: FDA PDF pp. 4, 6–8; clinical validation on p. 8.
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.