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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 K213684
Device Name SurgiCase Viewer
Applicant
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Aya Nishikawa
Correspondent
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Aya Nishikawa
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/22/2021
Decision Date 06/15/2022
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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