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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 K180961
Device Name RadiForce MX194
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 Received04/12/2018
Decision Date 05/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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