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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K152859
Device Name Portable X-ray System (Model: MINIX-V / MINIX-S)
Applicant
Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
309-311, 318-Ho, 145, Grasan Digital 1-Ro, Geumcheon-Gu
Seoul,  KR 153-787
Applicant Contact YOUNGBAE KWON
Correspondent
Innoden, LLC
212 Wells Ave. S #102
Renton,  WA  98057
Correspondent Contact YONG PARK
Regulation Number872.1800
Classification Product Code
EHD  
Date Received09/30/2015
Decision Date 12/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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