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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 K181609
Device Name RadiForce GX560, GX560-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 Received06/19/2018
Decision Date 08/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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