INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K112054
Device Name INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2441 michelle dr
tustin, 
CA 
92780

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

Correspodent Contact paul biggins
Regulation Number 892.1650
Classification Product Code
JAA  
Subsequent Product Code
IZI  
Date Received 07/19/2011
Decision Date 08/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No