OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K023207
Device Name OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
Original Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
tustin, 
CA 
92780

Original Contact michaela mahl
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 09/25/2002
Decision Date 10/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No