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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
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