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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K162497
Device Name 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
Applicant
EIZO CORPORATION
153 SHIMOKASHIWANO
HAKUSAN,  JP 924-8566
Applicant Contact Hiroaki Hashimoto
Correspondent
EIZO CORPORATION
153 SHIMOKASHIWANO
HAKUSAN,  JP 924-8566
Correspondent Contact Hiroaki Hashimoto
Regulation Number892.2050
Classification Product Code
PGY  
Date Received09/07/2016
Decision Date 09/19/2016
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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