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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 K241984
Device Name Hi-D Imaging 4TAVR
Applicant
Hi-D Imaging AG
Technoparkstrasse 2
Winterthur,  CH 8406
Applicant Contact Utku Gulan
Correspondent
Veranex, Inc.
5420 Wade Park Blvd.,
Suite 204
Raleigh,  NC  27607
Correspondent Contact Taras Bouzakine
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received07/08/2024
Decision Date 04/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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