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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 K040640
Device Name MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
Applicant
Igc-Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Applicant Contact ANTHONY DIETZLER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/10/2004
Decision Date 03/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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