| 510(k) Number |
K827289 |
| Device Name |
DIGITAL RADIOGRAPHY SYSTEM |
| Applicant |
| Diagnostic Technology, Inc. |
| Patriots Park |
|
Bedford,
MA
01730
|
|
| Correspondent |
| Diagnostic Technology, Inc. |
| Patriots Park |
|
Bedford,
MA
01730
|
|
| Date Received | 03/30/1982 |
| Decision Date | 04/21/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|