Vision Rt, Ltd.
Medical device manufacturer in London, GB.
11510(k) clearances
0PMA approvals
6recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253012 | AlignRT Plus (8.0)IYE · Traditional | 03/18/2026SE |
| K243301 | MapRTIYE · Traditional | 05/19/2025SE |
| K233622 | AlignRT PlusIYE · Traditional | 03/29/2024SE |
| 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 |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0998-2026 Class II | The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras…Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore… | 08/27/2025Open, Classified |
| Z-0065-2019 Class II | Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The…RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB | 08/24/2018Terminated |
| Z-2668-2016 Class II | TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528.…Vision RT Ltd received three (3) reports from different sites that discovered the following issue… | 06/30/2016Terminated |
| Z-2667-2016 Class II | AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use…Vision RT Ltd received three (3) reports from different sites that discovered the following issue… | 06/30/2016Terminated |
| Z-0934-2015 Class II | AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to…Potential use error when the external Gate Controller is turned ON after the Vision RT software has been… | 11/11/2014Terminated |
| Z-0464-2015 Class II | AlignRT- Intended for prescription use. The system is indicated for use during…Potential failure of AlignRT to assert interlock. | 10/15/2014Terminated |