DELTA 32 AND DELTA 32 TACT


definition

Device Classification Name

system, x-ray, mammographic

510(k) Number K002472
Device Name DELTA 32 AND DELTA 32 TACT
Original Applicant
INSTRUMENTARIUM IMAGING, INC.
300 west edgerton ave.
milwaukee, 
WI 
53207 -6025

Original Contact tommi jokiniemi
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 08/11/2000
Decision Date 11/29/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No