| Device Classification Name |
System, Simulation, Radiation Therapy
|
| 510(k) Number |
K884323 |
| Device Name |
XIMAVIEW(TM) |
| Applicant |
| Varian Assoc., Inc. |
| 611 Hansen Way |
| P.O. Box 10800 |
|
Palo Alto,
CA
94303
|
|
| Applicant Contact |
MILTON D SIEGEL |
| Correspondent |
| Varian Assoc., Inc. |
| 611 Hansen Way |
| P.O. Box 10800 |
|
Palo Alto,
CA
94303
|
|
| Correspondent Contact |
MILTON D SIEGEL |
| Regulation Number | 892.5840 |
| Classification Product Code |
|
| Date Received | 10/14/1988 |
| Decision Date | 04/03/1989 |
| 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
|
|
|