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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 K163335
Device Name 6MP Color LCD Monitor, RadiForce RX660, RX660-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 Received11/28/2016
Decision Date 12/15/2016
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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