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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 K191026
Device Name MEDIP PRO
7F Changkyung Building, 174, Yulgok-ro
Jongno-gu,  KR 03127
Applicant Contact Yoon Bo Chung
DT&S Co., Ltd.
#202, Mario Tower, 28, Digital-ro 30-gil
Guro-gu,  KR 08389
Correspondent Contact GeumHyeon Kim
Regulation Number892.2050
Classification Product Code
Date Received04/18/2019
Decision Date 11/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No