| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K925284 |
| Device Name |
IMAGESSSHARE 910 |
| Applicant |
| Dejarnette Research Systems |
| Suite 503 |
| 401 Washington Ave. |
|
Towson,
MD
21204
|
|
| Applicant Contact |
RICHARD E SMILLIE |
| Correspondent |
| Dejarnette Research Systems |
| Suite 503 |
| 401 Washington Ave. |
|
Towson,
MD
21204
|
|
| Correspondent Contact |
RICHARD E SMILLIE |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 10/20/1992 |
| Decision Date | 01/21/1993 |
| 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
|
|
|