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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K220727
Device Name inHEART MODELS
Applicant
Inheart, Sas
Ihu Liryc – Hôpital Xavier Arnozan-Ave. Du Haut Lévêque
Pessac,  FR 33600
Applicant Contact Audrey Labèque
Correspondent
Inheart, Sas
Ihu Liryc – Hôpital Xavier Arnozan-Ave. Du Haut Lévêque
Pessac,  FR 33600
Correspondent Contact Audrey Labèque
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/14/2022
Decision Date 05/10/2022
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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