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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K923536
Device Name NUCLEAR MEDICINE LASER IMAGER
Applicant
General Scanning, Inc.
500 Arsenal St.
Watertown,  MA  02172
Applicant Contact CATHERINE FOTHERGILL
Correspondent
General Scanning, Inc.
500 Arsenal St.
Watertown,  MA  02172
Correspondent Contact CATHERINE FOTHERGILL
Regulation Number892.2040
Classification Product Code
LMC  
Date Received07/16/1992
Decision Date 11/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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