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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software For Visualization Of Vascular Anatomy And Intravascular Devices
510(k) Number K253122
Device Name Sim&Size
Applicant
Sim&Cure
95 Rue Pierre Flourens Batiment H
Montpellier,  FR 34090
Applicant Contact Lucile Azema
Correspondent
Sim&Cure
95 Rue Pierre Flourens Batiment H
Montpellier,  FR 34090
Correspondent Contact Colette Maurin
Regulation Number892.2050
Classification Product Code
PZO  
Date Received09/25/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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