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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 K073448
Device Name MEDICAL DISPLAY, MD205MG
Applicant
Nec Display Solutions , Ltd.
686-1 Nishioi, Oi-Machi
Ashigarakami-Gun, Kanagawa,  JP 258-8533
Applicant Contact SHUICHI KINO
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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