PLANMED NUANCE EXCEL


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K111361
Device Name PLANMED NUANCE EXCEL
Applicant
PLANMECA USA, INC.
100 n. gary ave. suite a
roselle, 
IL 
60172

Applicant Contact bob pienkowski
Correspondent
PLANMECA USA, INC.
100 n. gary ave. suite a
roselle, 
IL 
60172

Correspodent Contact bob pienkowski
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 05/16/2011
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