EXTRA LARGE BODY COIL FOR OPART (MRT-600)


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K991057
Device Name EXTRA LARGE BODY COIL FOR OPART (MRT-600)
Applicant
TOSHIBA AMERICA MRI, INC.
280 utah ave.
south san francisco, 
CA 
94080 -6883

Applicant Contact ken nehmer
Correspondent
TOSHIBA AMERICA MRI, INC.
280 utah ave.
south san francisco, 
CA 
94080 -6883

Correspodent Contact ken nehmer
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 03/30/1999
Decision Date 05/20/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No