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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 K113226
Model RX840
Device Name 8MP COLOR LCD MONITOR,RADIFORCE RX840
Original Applicant
EIZO NANAO CORPORATION
153 shimokashiwano,
hakusan, ishikawa,  JA 924-8566
Original Contact hiroaki hashimoto
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/01/2011
Decision Date 12/17/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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