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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 K210237
Device Name CINA CHEST
Applicant
Avicenna.AI
93 avenue du Sorbiers, Zone Athelia IV
La Ciotat,  FR 13600
Applicant Contact Stephane Berger
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 Received01/28/2021
Decision Date 05/19/2021
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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