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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Automatic, Radiographic
510(k) Number K894142
Device Name ULTRANET-S COLLIMATOR
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 Number892.1610
Classification Product Code
IZW  
Date Received06/13/1989
Decision Date 11/06/1989
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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