VANTAGE TITAN HSR


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K112003
Device Name VANTAGE TITAN HSR
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin, 
CA 
92780

Applicant Contact paul biggins
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin, 
CA 
92780

Correspodent Contact paul biggins
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 07/13/2011
Decision Date 12/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes