Elekta Unity
FDA 510(k) K192482 · Elekta Limited
510(k) numberK192482
Submission
- Device name
- Elekta Unity
- Applicant
- Elekta Limited
Crawley, GB - Received
- September 10, 2019
- Decision date
- December 5, 2019
- 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 |
More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDIYE · Traditional | 06/11/2021SE |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHDIYE · Traditional | 11/22/2019SE |
| K190178 | Monaco RTP SystemMUJ · Traditional | 03/29/2019SE |
| K183037 | Monaco RTP SystemMUJ · Traditional | 12/04/2018SE |
| K183034 | MOSAIQ Oncology Information SystemIYE · Traditional | 12/04/2018SE |
| K182076 | Elekta UnityIYE · Traditional | 12/04/2018SE |
| K153011 | iViewDose R1.0IYE · Traditional | 12/11/2015SE |
| K141855 | ClarityIYE · Traditional | 10/08/2014SE |
| K131965 | Xvi R5.0IYE · Traditional | 09/25/2013SE |
| K123808 | AgilityIYE · Traditional | 04/04/2013SE |
Questions and answers
When was Elekta Unity cleared by the FDA?
Elekta Unity (K192482) received a 510(k) decision of Substantially Equivalent on December 5, 2019, 86 days after the submission was received.
What is the product code of K192482?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.