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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 K090062
Device Name WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
Applicant
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC
SUITE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI,  CN 200030
Applicant Contact Diana Hong
Correspondent
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC
SUITE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/09/2009
Decision Date 05/18/2009
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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