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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K970064
Device Name AMICAS WEB/INTRANET IMAGE SERVER
Applicant
Autocyt Group, Inc.
52 Marshall Steet
Watertown,  MA  02172
Applicant Contact ADRIAN GROPPER, M.D.
Correspondent
Autocyt Group, Inc.
52 Marshall Steet
Watertown,  MA  02172
Correspondent Contact ADRIAN GROPPER, M.D.
Regulation Number892.2020
Classification Product Code
LMD  
Date Received01/07/1997
Decision Date 03/17/1997
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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