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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 K232085
Device Name DVAS (DVAS-M, DVAS-W)
Applicant
Genoray Co., Ltd.
#512, 560, Dunchon-Daero, Jungwon-Gu
Seongnam-Si,  KR 13230
Applicant Contact Inyoung Kim
Correspondent
Genoray America, Inc.
1220 N Simon Cir.
Unit B
Anaheim,  CA  92806
Correspondent Contact Kaitlynn Min
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/13/2023
Decision Date 12/08/2023
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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