REX, VERSION 1.0


Device Classification Name

system, image processing, radiological

510(k) Number K021099
Device Name REX, VERSION 1.0
Original Applicant
POINTDX, INC
635 west fourth st.
suite 200
winston-salem, 
NC 
27101

Original Contact robert anderson
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/04/2002
Decision Date 06/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No