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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer Assisted Detection/Diagnosis Software For Fracture
510(k) Number K262062
Device Name CINA-Aneurysm
Applicant
Avicenna.Ai
Espace Mistral B, 375 Ave. Du Mistral
La Ciotat,  FR 13600
Applicant Contact Stéphane Berger
Correspondent
Hogan Lovells US LLP
Columbia Sq., 555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Classification Product Code
QBS  
Subsequent Product Codes
QFM   QIH  
Date Received06/18/2026
Decision Date 10/20/2026
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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