AlignRT Plus (8.0)
FDA 510(k) K253012 · Vision Rt, Ltd.
510(k) numberK253012
Submission
- Device name
- AlignRT Plus (8.0)
- Applicant
- Vision Rt, Ltd.
London, GB - Received
- September 19, 2025
- Decision date
- March 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Elekta Solutions AB
| 510(k) | Device | Decision |
|---|---|---|
| K243301 | MapRTIYE · Traditional | 05/19/2025SE |
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| K231185 | MapRTIYE · Traditional | 06/23/2023SE |
| K212583 | AlignRT PlusIYE · Traditional | 11/10/2021SE |
| K203387 | AlignRT PlusIYE · Traditional | 03/04/2021SE |
| K193431 | AlignRT PlusIYE · Special | 01/03/2020SE |
| K181218 | AlignRT PlusIYE · Traditional | 08/07/2018SE |
| K123371 | Alignrt PlusIYE · Traditional | 01/08/2013SE |
| K072171 | Gatect-RtIYE · Traditional | 10/01/2007SE |
| K052682 | AlignrtIYE · Traditional | 01/06/2006SE |
Questions and answers
When was AlignRT Plus (8.0) cleared by the FDA?
AlignRT Plus (8.0) (K253012) received a 510(k) decision of Substantially Equivalent on March 18, 2026, 180 days after the submission was received.
What is the product code of K253012?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.