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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 K050514
Device Name MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
Applicant
MRI DEVICES CORPORATION
N27 W23676 PAUL RD
PEWAUKEE,  WI  53072
Applicant Contact THOMAS SCHUBERT
Correspondent
MRI DEVICES CORPORATION
N27 W23676 PAUL RD
PEWAUKEE,  WI  53072
Correspondent Contact THOMAS SCHUBERT
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/01/2005
Decision Date 03/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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