SAMSUNG RAYPAX LONG TERM ARCHIVE


Device Classification Name

device, digital image storage, radiological

510(k) Number K992131
Device Name SAMSUNG RAYPAX LONG TERM ARCHIVE
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 892.2010
Classification Product Code
LMB  
Date Received 06/23/1999
Decision Date 09/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No