The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Radixact Treatment Delivery System.
| Device ID | K161146 |
| 510k Number | K161146 |
| Device Name: | Radixact Treatment Delivery System |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCURAY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
| Contact | Keith Picker |
| Correspondent | Keith Picker ACCURAY INCORPORATED 1209 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 | 2016-04-22 |
| Decision Date | 2016-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M65810600000 | K161146 | 000 |
| 00811376030047 | K161146 | 000 |