PERFORMA STEREO


Device Classification Name

system, x-ray, mammographic

510(k) Number K023864
Device Name PERFORMA STEREO
Original Applicant
INSTRUMENTARIUM CORP. IMAGING DIVISION
300 west edgerton ave.
milwaukee, 
WI 
53207

Original Contact brian broncatti
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 11/20/2002
Decision Date 01/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No