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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K961160
Device Name UPACS VERSION 1.7
Applicant
Base Ten Systems, Inc.
One Electtonics Dr.
P.O. Box 3151
Trenton,  NJ  08619
Applicant Contact RICHARD J FARRELLY
Correspondent
Base Ten Systems, Inc.
One Electtonics Dr.
P.O. Box 3151
Trenton,  NJ  08619
Correspondent Contact RICHARD J FARRELLY
Regulation Number892.2010
Classification Product Code
LMB  
Date Received03/22/1996
Decision Date 06/11/1996
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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