| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K973303 |
| Device Name |
IMATION MODEL 9410 NETWORK INTERFACE |
| Applicant |
| Imation Corp. |
| 3m Center, 235-2b-23 |
|
St. Paul,
MN
55144 -1000
|
|
| Applicant Contact |
STEPHEN G SLAVENS |
| Correspondent |
| Imation Corp. |
| 3m Center, 235-2b-23 |
|
St. Paul,
MN
55144 -1000
|
|
| Correspondent Contact |
STEPHEN G SLAVENS |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 09/03/1997 |
| Decision Date | 11/25/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|