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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 K170702
Device Name mediCAD 4.0
mediCAD Hectec Gmbh
Opalstrasse 54
Altdorf,  DE 84032
Applicant Contact Claas-Fabian Luers
mediCAD Hectec Gmbh
Opalstrasse 54
Altdorf,  DE 84032
Correspondent Contact Claas-Fabian Luers
Regulation Number892.2050
Classification Product Code
Date Received03/08/2017
Decision Date 09/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No