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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
Predetermined Change
Control Plan Authorized		 No
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