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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 K060136
Device Name PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR
Applicant
Planar Systems, Inc.
1195 NW Compton Dr.
Beaverton,  OR  97006
Applicant Contact CRAIG HARSHMAN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MELISSA J DEGUIA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/19/2006
Decision Date 01/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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