Brainomix 360 Hyperdensity— 510(k) K260406

Name: FDA 510(k) clearance K260406
Creator: U.S. Food and Drug Administration
Published: 2026-06-12

Substantially Equivalent

Brainomix Limited

FDA 510(k) clearance K260406 for Brainomix 360 Hyperdensity, Substantially Equivalent on 2026-06-12. Applicant: Brainomix Limited. Device class: 2.

Summary

Brainomix's Brainomix 360 Hyperdensity is filed under QIH, automated radiological image processing software. The record doesn't describe the software beyond its name and the code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Brainomix filed from Oxford, United Kingdom. Review took 123 calendar days (February 9 to June 12, 2026).

Clearance details

Applicant: Brainomix Limited
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-02-09
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.