Device Classification Name |
Device, Digital Image Storage, Radiological
|
510(k) Number |
K973463 |
Device Name |
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE |
Applicant |
OTECH, INC. |
6741 GRANT LN. |
PLANO,
TX
75024
|
|
Applicant Contact |
HERMAN OOSTERWIJCK |
Correspondent |
OTECH, INC. |
6741 GRANT LN. |
PLANO,
TX
75024
|
|
Correspondent Contact |
HERMAN OOSTERWIJCK |
Regulation Number | 892.2010
|
Classification Product Code |
|
Date Received | 09/12/1997 |
Decision Date | 12/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|