SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0


Device Classification Name

system, image processing, radiological

510(k) Number K112439
Device Name SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Applicant Contact jyh-shyan lin
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Correspodent Contact jyh-shyan lin
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/24/2011
Decision Date 10/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No