| Device Classification Name |
Camera, Multi Format, Radiological
|
| 510(k) Number |
K914834 |
| Device Name |
VORTECH 3M NETWORK PRINTING |
| Applicant |
| Vortech Data, Inc. |
| 2929 N. Central Expressway |
| Suite 101 |
|
Richardson,
TX
75080
|
|
| Applicant Contact |
KEM MYERS |
| Correspondent |
| Vortech Data, Inc. |
| 2929 N. Central Expressway |
| Suite 101 |
|
Richardson,
TX
75080
|
|
| Correspondent Contact |
KEM MYERS |
| Regulation Number | 892.2040 |
| Classification Product Code |
|
| Date Received | 10/25/1991 |
| Decision Date | 03/06/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|