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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 K183412
Device Name mediCAD Web
Applicant
mediCAD Hectec GmbH
Opalstrasse 54
Altdorf,  DE 84032
Applicant Contact Claas-Fabian Lueers
Correspondent
mediCAD Hectec GmbH
Opalstrasse 54
Altdorf,  DE 84032
Correspondent Contact Claas-Fabian Lueers
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/2018
Decision Date 10/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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