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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 K090045
Device Name COLOR LCD MONITOR, RADIFORCE RX320
Applicant
Eizo Nanao Corporation
153 Shimokashiwano-Cho
Hakusan, Ishikawa-Ken,  JP 924-8566
Applicant Contact HIROAKI HASHIMOTO
Correspondent
Eizo Nanao Corporation
153 Shimokashiwano-Cho
Hakusan, Ishikawa-Ken,  JP 924-8566
Correspondent Contact HIROAKI HASHIMOTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/07/2009
Decision Date 01/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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