REX, VERSION 3.0


Device Classification Name

system, image processing, radiological

510(k) Number K030457
Device Name REX, VERSION 3.0
Applicant
POINTDX, INC
635 west fourth st.
suite 200
winston-salem, 
NC 
27101

Applicant Contact francis bonk
Correspondent
POINTDX, INC
635 west fourth st.
suite 200
winston-salem, 
NC 
27101

Correspodent Contact francis bonk
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/11/2003
Decision Date 04/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No