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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 K170419
Device Name SurgiCase Viewer
Materialise NV
Technologielaan 15
leuven,  BE 3001
Applicant Contact oliver clemens
Materialise NV
Technologielaan 15
leuven,  BE 3001
Correspondent Contact oliver clemens
Regulation Number892.2050
Classification Product Code
Date Received02/13/2017
Decision Date 05/11/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No