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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 K043412
Device Name MODIFICATION TO: VIEWSTATION
Applicant
Impac Medical Systems, Inc.
100 W. Evelyn Ave.
Mountain View,  CA  94041 -1464
Applicant Contact THOMAS H FARIS
Correspondent
Impac Medical Systems, Inc.
100 W. Evelyn Ave.
Mountain View,  CA  94041 -1464
Correspondent Contact THOMAS H FARIS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/2004
Decision Date 12/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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