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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K980565
Device Name LD2000 SERIES
Applicant
General Scanning, Inc.
500 Arsenal St.
Watertown,  MA  02172
Applicant Contact STEVEN P ZIS
Correspondent
General Scanning, Inc.
500 Arsenal St.
Watertown,  MA  02172
Correspondent Contact STEVEN P ZIS
Regulation Number892.2030
Classification Product Code
LMA  
Date Received02/13/1998
Decision Date 03/19/1998
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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