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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K231683
Device Name inHEART Models
Applicant
inHEART, SAS
IHU LIryc – Hôpital Xavier Arnozan-Avenue du Haut Lévêque
Pessac,  FR 33600
Applicant Contact Audrey Labeque
Correspondent
inHEART, SAS
IHU LIryc – Hôpital Xavier Arnozan-Avenue du Haut Lévêque
Pessac,  FR 33600
Correspondent Contact Audrey Labeque
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received06/09/2023
Decision Date 02/29/2024
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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