SAMSUNG RAYPAX DISPLAY WORKSTATION


Device Classification Name

system, image processing, radiological

510(k) Number K992306
Device Name SAMSUNG RAYPAX DISPLAY WORKSTATION
Applicant
SAMSUNG SDS CO., LTD
2001 east oakshores dr.
aubrey, 
TX 
76227

Applicant Contact carl alletto
Correspondent
SAMSUNG SDS CO., LTD
2001 east oakshores dr.
aubrey, 
TX 
76227

Correspodent Contact carl alletto
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/09/1999
Decision Date 09/22/1999
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Radiology

510k Review Panel

Radiology
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No