The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Clearrt Helical Kvct For The Radixact Treatment Delivery System.
| Device ID | K202412 |
| 510k Number | K202412 |
| Device Name: | ClearRT Helical KVCT For The Radixact Treatment Delivery System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Accuray Incorporated 1240 Deming Way Madison, WI 53717 |
| Contact | Keith Picker |
| Correspondent | Keith Picker Accuray Incorporated 1240 Deming Way Madison, WI 53717 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-24 |
| Decision Date | 2020-12-18 |