GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K111434
Device Name GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
Applicant
GIOTTO USA, LLC
9001 wesleyan road
suite 200
indianapolis, 
IN 
46268

Applicant Contact patrick mooney
Correspondent
GIOTTO USA, LLC
9001 wesleyan road
suite 200
indianapolis, 
IN 
46268

Correspodent Contact patrick mooney
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 05/23/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No