IMAGECHECKER-CT WORKSTATION


Device Classification Name

system, image processing, radiological

510(k) Number K023003
Device Name IMAGECHECKER-CT WORKSTATION
Original Applicant
R2 TECHNOLOGY, INC.
1195 w. fremont ave.
sunnyvale, 
CA 
94087

Original Contact kathy o’shaughnessy
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/09/2002
Decision Date 11/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No