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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 Prioritization Software For Lesions
510(k) Number K240612
Device Name CINA-VCF
Applicant
Avicenna.AI
ZI Athelia, 297 Av. du Mistral Bât. A,
La Ciotat,  FR 13600
Applicant Contact Stephane Berger
Correspondent
Hogan Lovells, US LLP
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number892.2080
Classification Product Code
QFM  
Date Received03/05/2024
Decision Date 05/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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