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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 K200855
Device Name CINA
Applicant
AVICENNA.AI
93 avenue des Sorbiers, Zone Athelia IV
La Ciotat,  FR 13600
Applicant Contact Cyril Di Grandi
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received03/31/2020
Decision Date 06/24/2020
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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