MAMMODIAGNOST DR


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K110572
Device Name MAMMODIAGNOST DR
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Applicant Contact linda jalbert
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Correspodent Contact linda jalbert
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 03/01/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No