| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K924178 |
| Device Name |
MEDVISION(TM) IMAGING SOFTWARE |
| Applicant |
| EVERGREEN TECHNOLOGIES, INC. |
| DIAMOND FARM OFFICE PARK |
| 849-M QUINCE ORCHARD BOULEVARD |
|
GAITHERSBURG,
MD
20850
|
|
| Applicant Contact |
KAREN SIEGEL |
| Correspondent |
| EVERGREEN TECHNOLOGIES, INC. |
| DIAMOND FARM OFFICE PARK |
| 849-M QUINCE ORCHARD BOULEVARD |
|
GAITHERSBURG,
MD
20850
|
|
| Correspondent Contact |
KAREN SIEGEL |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 08/19/1992 |
| Decision Date | 02/02/1993 |
| 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
|
|
|