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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 K233217
Device Name Mimics Cardiac Planner
Applicant
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Victoria Becheva
Correspondent
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Victoria Becheva
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/28/2023
Decision Date 02/12/2024
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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