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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 K024200
Device Name INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
Applicant
Ge Medical Systems, Inc.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
Ge Medical Systems, Inc.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact LARRY A KROGER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received12/20/2002
Decision Date 01/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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