LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K023982
Device Name LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL
Original Applicant
USA INSTRUMENTS, INC.
1515 danner dr.
aurora, 
OH 
44202

Original Contact christie shumaker
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 12/02/2002
Decision Date 02/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No