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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 K022970
Device Name AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
Applicant
AMICAS, INC.
20 GUEST ST.
BRIGHTON,  MA  02135
Applicant Contact PATRICE NEDELEC
Correspondent
AMICAS, INC.
20 GUEST ST.
BRIGHTON,  MA  02135
Correspondent Contact PATRICE NEDELEC
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/06/2002
Decision Date 11/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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