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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 K090947
Device Name 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
Applicant
Totoku Electric Co., Ltd.
300 Oya, Ueda
Nagano,  JP 386-0192
Applicant Contact MIKIO HASEGAWA
Correspondent
Totoku Electric Co., Ltd.
300 Oya, Ueda
Nagano,  JP 386-0192
Correspondent Contact MIKIO HASEGAWA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/03/2009
Decision Date 08/16/2010
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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