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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K932957
Device Name QUANTEM (TM)
Applicant
GE Medical Systems
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact LARRY KROGER
Correspondent
GE Medical Systems
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact LARRY KROGER
Regulation Number892.1100
Classification Product Code
IYX  
Date Received06/17/1993
Decision Date 08/05/1993
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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