| Device Classification Name |
System, Therapeutic, X-Ray
|
| 510(k) Number |
K871810 |
| Device Name |
PLAN-32 SOFTWARE |
| Applicant |
| Oncology Systems, Inc. |
| 10777 Main St. Suite 20 |
|
Bellevue,
WA
98004
|
|
| Applicant Contact |
ANTHONY C NAUGHTIN |
| Correspondent |
| Oncology Systems, Inc. |
| 10777 Main St. Suite 20 |
|
Bellevue,
WA
98004
|
|
| Correspondent Contact |
ANTHONY C NAUGHTIN |
| Regulation Number | 892.5900 |
| Classification Product Code |
|
| Date Received | 05/08/1987 |
| Decision Date | 10/30/1987 |
| 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
|
|
|