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
|
|
Correspondent Contact |
CARL ALLETTO |
Regulation Number | 892.2010
|
Classification Product Code |
|
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
|
|
|