The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Accuray Precision Treatment Planning System.
| Device ID | K212794 |
| 510k Number | K212794 |
| Device Name: | Accuray Precision Treatment Planning System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Accuray Incorporated 1209 Deming Way Madison, WI 53717 |
| Contact | Lizhi Yu |
| Correspondent | Lizhi Yu Accuray Incorporated 1209 Deming Way Madison, WI 53717 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-02 |
| Decision Date | 2021-09-30 |