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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 K973411
Device Name DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
Applicant
GENERAL SCANNING, INC.
500 ARSENAL ST.
WATERTOWN,  MA  02172
Applicant Contact WALTER J LESLIE
Correspondent
GENERAL SCANNING, INC.
500 ARSENAL ST.
WATERTOWN,  MA  02172
Correspondent Contact WALTER J LESLIE
Regulation Number892.2030
Classification Product Code
LMA  
Date Received09/09/1997
Decision Date 12/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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