| Device Classification Name |
Device, Digital Image Storage, Radiological
|
|---|
| 510(k) Number |
K891690 |
|---|
| Device Name |
KODAK EKTASCAN IMAGE MANAGER |
|---|
| Applicant |
| Eastman Kodak Company |
| 343 State St. |
|
Rochester,
NY
14650
|
|
| Applicant Contact |
NORMAN H GEIL |
| Correspondent |
| Eastman Kodak Company |
| 343 State St. |
|
Rochester,
NY
14650
|
|
| Correspondent Contact |
NORMAN H GEIL |
| Regulation Number | 892.2010 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/22/1989 |
|---|
| Decision Date | 06/15/1989 |
|---|
| 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
|
|---|