MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION


Device Classification Name

system, x-ray, mammographic

510(k) Number K960381
Device Name MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
Applicant
ELSCINT, INC.
505 main st.
suite 300
hackensack, 
NJ 
07601

Applicant Contact thomas j spackman, m.d., f.a.c.r.
Correspondent
ELSCINT, INC.
505 main st.
suite 300
hackensack, 
NJ 
07601

Correspodent Contact thomas j spackman, m.d., f.a.c.r.
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 01/26/1996
Decision Date 04/29/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No