CALSCOR SOFTWARE


Device Classification Name

system, image processing, radiological

510(k) Number K021913
Device Name CALSCOR SOFTWARE
Original Applicant
3D MED CO., LTD.
49 plain st.
north attleboro, 
MA 
02760

Original Contact mary mcnamara-cullinane
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/11/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No