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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 K233968
Device Name CINA-iPE
Applicant
Avicenna.AI
ZI Athelia, 297 Av. du Mistral Bat. A
La Ciotat,  FR 13600
Applicant Contact Stephane Berger
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20005
Correspondent Contact John Smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received12/15/2023
Decision Date 03/13/2024
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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