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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K181943
Device Name OSCAR (OSCAR Prime, OSCAR Classic)
Applicant
Genoray Co., Ltd.
512, 560, Dunchon-daero, Jungwon-gu
Seongnam,  KR 13230
Applicant Contact Jeff Hwang
Correspondent
Genoray America Inc.
147 E. Bristol Lane
Orange,  CA  92780
Correspondent Contact Kaitlynn Min
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/20/2018
Decision Date 08/17/2018
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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