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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 K112466
Device Name 4MP COLOR LCD MONITOR, RADIFORCERX430
Applicant
Eizo Nanao Corporation
153 Shimokashiwano, Hakusan
Ishikawa,  JP 924-8566
Applicant Contact HIROAKI HASHIMOTO
Correspondent
Eizo Nanao Corporation
153 Shimokashiwano, Hakusan
Ishikawa,  JP 924-8566
Correspondent Contact HIROAKI HASHIMOTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/26/2011
Decision Date 10/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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