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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 K133686
Device Name 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)
Applicant
Jvckenwood Corporation
3-12, Moriyacho, Kanagawa-Ku
Yokohama-Shi, Kanagawa,  JP 221-0022
Applicant Contact TSUKASA TASHIRO
Correspondent
Jvckenwood Corporation
3-12, Moriyacho, Kanagawa-Ku
Yokohama-Shi, Kanagawa,  JP 221-0022
Correspondent Contact TSUKASA TASHIRO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/02/2013
Decision Date 01/06/2014
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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