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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K936180
Device Name TC+ SYSTEM (TILTING C-ARM SYSTEM)
Applicant
GE Medical Systems
3000 N. Grandview Blvd.
W-709
Waukesha,  WI  53188
Correspondent
GE Medical Systems
3000 N. Grandview Blvd.
W-709
Waukesha,  WI  53188
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received12/27/1993
Decision Date 03/16/1994
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
Recalls CDRH Recalls
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