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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 K972103
Device Name PHILIPS EASYVISION
Applicant
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484 -0197
Applicant Contact PETER ALTMAN
Correspondent
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484 -0197
Correspondent Contact PETER ALTMAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/04/1997
Decision Date 09/02/1997
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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