DELTA 32; DELTA 32 TACT


Device Classification Name

system, x-ray, mammographic

510(k) Number K022275
Device Name DELTA 32; DELTA 32 TACT
Original Applicant
INSTRUMENTARIUM CORP. IMAGING DIVISION
300 west edgerton ave.
milwaukee, 
WI 
53207

Original Contact darren grebe
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 07/15/2002
Decision Date 09/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No