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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K113784
Device Name 3MP MONOCHROME LCD MONITOR, RADIFORCE GX40
Original Applicant
EIZO NANAO CORPORATION
153 shimokashiwano
iiakusan,  JP 924-8566
Original Contact hiroaki hashimoto
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/22/2011
Decision Date 03/02/2012
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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