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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 K042353
Device Name AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS
Applicant
National Display Systems
16245 Vineyard Blvd.
Morgan Hill,  CA  95037
Applicant Contact RON HANSEN
Correspondent
National Display Systems
16245 Vineyard Blvd.
Morgan Hill,  CA  95037
Correspondent Contact RON HANSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/30/2004
Decision Date 11/24/2004
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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