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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 K130935
Device Name DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
Applicant
RAYENCE CO., LTD
12946 KIMBERLEY LN
HOUSTON,  TX  77079
Applicant Contact DAVE KIM
Correspondent
RAYENCE CO., LTD
12946 KIMBERLEY LN
HOUSTON,  TX  77079
Correspondent Contact DAVE KIM
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/04/2013
Decision Date 07/02/2013
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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