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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K972990
Device Name MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
Applicant
GE MEDICAL SYSTEMS
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGERR
Correspondent
GE MEDICAL SYSTEMS
3200 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact LARRY A KROGERR
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/12/1997
Decision Date 02/05/1998
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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