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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
510(k) Number K243769
Device Name QFR (3.0)
Applicant
Qfr Solutions BV
Schuttersveld 9
Leiden,  NL 2316XG
Applicant Contact Bob Goedhart
Correspondent
Qfr Solutions BV
Schuttersveld 9
Leiden,  NL 2316XG
Correspondent Contact Bob Goedhart
Regulation Number892.1600
Classification Product Code
QHA  
Subsequent Product Code
LLZ  
Date Received12/06/2024
Decision Date 04/04/2025
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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