PLANMED NUANCE DIGIGUIDE


Device Classification Name

full field digital,system,x-ray,mammographic

510(k) Number K121963
Device Name PLANMED NUANCE DIGIGUIDE
Applicant
PLANMED OY
asentajankatu 6
sorvaajankatu 7
helsinki, 

FI

fi-00880

Applicant Contact lars moring
Correspondent
PLANMED OY
asentajankatu 6
sorvaajankatu 7
helsinki, 

FI

fi-00880

Correspodent Contact lars moring
Regulation Number 892.1715
Classification Product Code
MUE  
Date Received 07/05/2012
Decision Date 11/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No