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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 Triage And Notification Software
510(k) Number K240942
Device Name CINA-CSpine
Applicant
Avicenna.AI
Espace Mistral B, 375 avenue du Mistral
La Ciotat,  FR 13600
Applicant Contact Stephane Berger
Correspondent
Hogan Lovells, US LLP
Columbia Square
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John J. Smith, M.D., J.D.
Regulation Number892.2080
Classification Product Code
QAS  
Date Received04/05/2024
Decision Date 09/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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