SYNAPSE 3D CARDIAC TOOLS


Device Classification Name

system, image processing, radiological

510(k) Number K103465
Device Name SYNAPSE 3D CARDIAC TOOLS
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Applicant Contact debbie peacock
Correspondent
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Correspodent Contact debbie peacock
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/24/2010
Decision Date 01/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No