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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K242119
Device Name INNOVISION-EXII
Applicant
Dk Medical System
52, Chupalsandan 1-Gil, Paengseong-Eup
Pyeongtaek-Si,  KR 17998
Applicant Contact Sung-moon Hong
Correspondent
Mtechgroup
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Kim Dave
Regulation Number892.1680
Classification Product Code
KPR  
Date Received07/19/2024
Decision Date 01/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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