Vision RT Ltd
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0998-2026 | Class II | The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track th | August 27, 2025 |
| Z-0065-2019 | Class II | Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a | August 24, 2018 |
| Z-2667-2016 | Class II | AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to positio | June 30, 2016 |
| Z-2668-2016 | Class II | TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBea | June 30, 2016 |
| Z-0934-2015 | Class II | AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the sk | November 11, 2014 |
| Z-0464-2015 | Class II | AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup an | October 15, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253012 | AlignRT Plus (8.0) | March 18, 2026 |
| K243301 | MapRT | May 19, 2025 |
| K233622 | AlignRT Plus | March 29, 2024 |
| K231185 | MapRT | June 23, 2023 |
| K212583 | AlignRT Plus | November 10, 2021 |
| K203387 | AlignRT Plus | March 4, 2021 |
| K193431 | AlignRT Plus | January 3, 2020 |
| K181218 | AlignRT Plus | August 7, 2018 |