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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 K211966
Device Name Segment 3DPrint
Medviso AB
Griffelvägen 3
Lund,  SE SE-22467
Applicant Contact Einar Heiberg
Medviso AB
Griffelvägen 3
Lund,  SE SE-22467
Correspondent Contact Einar Heiberg
Regulation Number892.2050
Classification Product Code
Date Received06/24/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No