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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 K232147
Device Name CAAS Workstation
Applicant
Pie Medical Imaging BV
Philipsweg 1
Maastricht,  NL 6227 AJ
Applicant Contact Annemiek Bouts
Correspondent
Pie Medical Imaging BV
Philipsweg 1
Maastricht,  NL 6227 AJ
Correspondent Contact Annemiek Bouts
Regulation Number892.1600
Classification Product Code
QHA  
Subsequent Product Code
LLZ  
Date Received07/19/2023
Decision Date 04/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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