FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K110202
Device Name FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford, 
CT 
06902

Applicant Contact katherine y choi
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received 01/24/2011
Decision Date 02/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No