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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 K033292
Device Name AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
Applicant
Igc-Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Applicant Contact ANTHONY DIETZLER
Correspondent
Igc-Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Correspondent Contact ANTHONY DIETZLER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/14/2003
Decision Date 11/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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