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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 K974207
Device Name PHILIPS EASYVISION WORKSTATION
Applicant
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Applicant Contact PETER ALTMAN
Correspondent
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Correspondent Contact PETER ALTMAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/10/1997
Decision Date 01/22/1998
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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