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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 K091090
Device Name DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
Applicant
E-Woo Technology
256 N. Sam Houston Pkwy. E.
Suite 115
Houston,  TX  77060
Applicant Contact VINCENT LEE
Correspondent
E-Woo Technology
256 N. Sam Houston Pkwy. E.
Suite 115
Houston,  TX  77060
Correspondent Contact VINCENT LEE
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/16/2009
Decision Date 08/09/2010
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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