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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 K983815
Device Name PACSCACHE
Applicant
Dome Imaging Systems, Inc.
400 Fifth Ave.
Waltham,  MA  02451
Applicant Contact MORTEZA MINAEE
Correspondent
Dome Imaging Systems, Inc.
400 Fifth Ave.
Waltham,  MA  02451
Correspondent Contact MORTEZA MINAEE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/28/1998
Decision Date 01/14/1999
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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