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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 K042207
Device Name 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
Applicant
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Applicant Contact JAMES WRENN
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 Received08/16/2004
Decision Date 08/26/2004
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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