Aurora-RT
FDA 510(k) K213526 · Magnettx Oncology Solutions , Ltd.
510(k) numberK213526
Submission
- Device name
- Aurora-RT
- Applicant
- Magnettx Oncology Solutions , Ltd.
Edmonton, CA - Received
- November 4, 2021
- Decision date
- May 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | Radformation, Inc. | 08/31/2026SE |
| K260733 | MRIA Radiation Therapy Information System (MRIA)IYE · Traditional | Manteia Technologies Co., Ltd. | 08/26/2026SE |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 08/03/2026SE |
| K252937 | ThinkQA 3IYE · Traditional | Dosisoft SA | 06/12/2026SE |
| K253004 | Luna 3DIYE · Traditional | Lap GmbH Laser Applikationen | 06/04/2026SE |
| K260792 | AerFrame Patient Immobilization System (AFPIS)IYE · Traditional | Stabilix, LLC | 05/08/2026SE |
| K252258 | Veriqa RT Epid 3DIYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten… | 04/15/2026SE |
| K253962 | ClearCheck (RADCC V2.7)IYE · Traditional | Radformation, Inc. | 04/03/2026SE |
| K253012 | AlignRT Plus (8.0)IYE · Traditional | Vision Rt, Ltd. | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 01/21/2026SE |
Questions and answers
When was Aurora-RT cleared by the FDA?
Aurora-RT (K213526) received a 510(k) decision of Substantially Equivalent on May 4, 2022, 181 days after the submission was received.
What is the product code of K213526?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.