PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)


Device Classification Name

system, x-ray, mammographic

510(k) Number K021945
Device Name PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
Original Applicant
PLANMED OY
100 north gray ave. suite a
roselle, 
IL 
60172

Original Contact bob pienkowski
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 06/13/2002
Decision Date 02/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No