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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 K042186
Device Name 3.0T 8-CHANNEL CTL SPINE ARRAY
Applicant
USA INSTRUMENTS, INC.
1515 DANNER DR.
AURORA,  OH  44202
Applicant Contact JAMES WRENN
Correspondent
USA INSTRUMENTS, INC.
1515 DANNER DR.
AURORA,  OH  44202
Correspondent Contact JAMES WRENN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/12/2004
Decision Date 08/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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