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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 K120451
Device Name 8MP COLOR LCD MONITOR, REDIFORCE RX840
Original Applicant
EIZO NANAO CORPORATION
153 shimokashiwano
hakusan,  JP 924-8566
Original Contact hiroaki hashimoto
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/14/2012
Decision Date 08/03/2012
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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