Cleared Traditional

Brainomix 360 e-ASPECTS

K243294 · Brainomix Limited · Radiology
Feb 2025
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K243294 is an FDA 510(k) clearance for the Brainomix 360 e-ASPECTS, a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code POK), submitted by Brainomix Limited (Oxford, GB). The FDA issued a Cleared decision on February 14, 2025, 119 days after receiving the submission on October 18, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2060.

Submission Details

510(k) Number K243294 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2024
Decision Date February 14, 2025
Days to Decision 119 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code POK — Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images