The following data is part of a premarket notification filed by Northwest Medical Physics Center with the FDA for Stereotactic Irradiation System.
| Device ID | K904908 |
| 510k Number | K904908 |
| Device Name: | STEREOTACTIC IRRADIATION SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | NORTHWEST MEDICAL PHYSICS CENTER 21031 67TH AVE. W. Lynnwood, WA 98036 |
| Contact | Andrew Jones |
| Correspondent | Andrew Jones NORTHWEST MEDICAL PHYSICS CENTER 21031 67TH AVE. W. Lynnwood, WA 98036 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-31 |
| Decision Date | 1991-06-06 |