The following data is part of a premarket notification filed by Magnettx Oncology Solutions Ltd. with the FDA for Aurora-rt.
| Device ID | K213526 |
| 510k Number | K213526 |
| Device Name: | Aurora-RT |
| Classification | Accelerator, Linear, Medical |
| Applicant | MagnetTx Oncology Solutions Ltd. 9505 41 Avenue NW Edmonton, CA T6e 5x7 |
| Contact | Michael Cook |
| Correspondent | Michael Cook MagnetTx Oncology Solutions Ltd. 9505 41 Avenue NW Edmonton, CA T6e 5x7 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-04 |
| Decision Date | 2022-05-04 |