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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 K172810
Device Name PORT-X IV
Applicant
Genoray Co., Ltd.
#512, 560, Dunchon-Daero, Jungwon-Gu
Seongnam-Si,  KR 13230
Applicant Contact Ji-Yeon Choi
Correspondent
Genoray America, Inc.
147 E. Bristol Ln.
Orange,  CA  92780
Correspondent Contact Chris Yoon
Regulation Number872.1800
Classification Product Code
EHD  
Date Received09/18/2017
Decision Date 03/07/2018
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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