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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K143000
Device Name RIS500
Applicant
Ray Co., Ltd.
332-7, Samsung 1-Ro
Hwaseong-Si,  KR 443-823
Applicant Contact KYUNGHA SEO
Correspondent
Andrew Paeng
4747 Hoen Ave.
Santa Rosa,  CA  95405
Correspondent Contact ANDREW PAENG
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/17/2014
Decision Date 01/23/2015
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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