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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K980322
Device Name ACCENT 16, ACCENT 22
Applicant
GE MEDICAL SYSTEMS
3000 N GRANDVIEW BLVD.
W-709
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER, PH.D.
Correspondent
GE MEDICAL SYSTEMS
3000 N GRANDVIEW BLVD.
W-709
WAUKESHA,  WI  53188
Correspondent Contact LARRY A KROGER, PH.D.
Regulation Number892.1650
Classification Product Code
OXO  
Date Received01/27/1998
Decision Date 04/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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