| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K864854 |
| Device Name |
VIEW(TM) IMAGE PROCESSING AND VIEWING STATION |
| Applicant |
| Virtual Imaging |
| 155 San Gabriel Dr. |
|
Sunnyvale,
CA
94086
|
|
| Applicant Contact |
ANDERSEN |
| Correspondent |
| Virtual Imaging |
| 155 San Gabriel Dr. |
|
Sunnyvale,
CA
94086
|
|
| Correspondent Contact |
ANDERSEN |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 12/11/1986 |
| Decision Date | 02/26/1987 |
| 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
|
|
|