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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K260406
Device Name Brainomix 360 Hyperdensity
Applicant
Brainomix Limited
First Floor Seacourt Tower
West Way
Oxford,  GB OX2 0JJ
Applicant Contact Zsolt Szrnka
Correspondent
Brainomix Limited
First Floor Seacourt Tower
West Way
Oxford,  GB OX2 0JJ
Correspondent Contact Zsolt Szrnka
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/09/2026
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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