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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K003613
Device Name 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
Applicant
GE Medical Systems
P.O.Box 414
Milwaukee,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
GE Medical Systems
P.O.Box 414
Milwaukee,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/22/2000
Decision Date 04/03/2001
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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