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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 K090742
Device Name DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
Applicant
SAMSUNG MOBILE DISPLAY CO., LTD
256 NORTH SAM HOUSTON PKWY E
#115
HOUSTON,  TX  77060
Applicant Contact VINCENT LEE
Correspondent
SAMSUNG MOBILE DISPLAY CO., LTD
256 NORTH SAM HOUSTON PKWY E
#115
HOUSTON,  TX  77060
Correspondent Contact VINCENT LEE
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/20/2009
Decision Date 09/18/2009
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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