4CH FLEX SPEEDER


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K111251
Device Name 4CH FLEX SPEEDER
Applicant
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 michelle dr
tustin, 
CA 
92780

Applicant Contact paul biggins
Correspondent
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 michelle dr
tustin, 
CA 
92780

Correspodent Contact paul biggins
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 05/04/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No