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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K233342
Device Name CINA-ASPECTS
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  20004
Correspondent Contact John J. Smith
Regulation Number892.2060
Classification Product Code
POK  
Date Received09/29/2023
Decision Date 03/15/2024
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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