MODIFICATION TO MEDSTATION


Device Classification Name

system, image processing, radiological

510(k) Number K021934
Device Name MODIFICATION TO MEDSTATION
Original Applicant
AISOFTW@RE MEDICAL, S.P.A.
719 catalpa ave.
teaneck, 
NJ 
07666

Original Contact diana upton
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/12/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No