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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 K251964
Device Name Mimics Thoracic Planner
Applicant
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Victoria Becheva
Correspondent
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Victoria Becheva
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/26/2025
Decision Date 03/12/2026
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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