JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K073081
Device Name JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin, 
CA 
92781 -2068

Applicant Contact paul biggins
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 11/01/2007
Decision Date 11/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No