CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K111324
Device Name CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
Applicant
AGFA HEALTHCARE N.V.
10 s academy street
greenville, 
SC 
29601

Applicant Contact phil cuscuna
Correspondent
AGFA HEALTHCARE N.V.
10 s academy street
greenville, 
SC 
29601

Correspodent Contact phil cuscuna
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 05/11/2011
Decision Date 12/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No