Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Vision RT with 11 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Mar 18, 2026: AlignRT Plus (8.0).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 18, 2026 | AlignRT Plus (8.0)K253012 · IYE | 510(k) clearances |
| May 19, 2025 | MapRTK243301 · IYE | 510(k) clearances |
| Mar 29, 2024 | AlignRT PlusK233622 · IYE | 510(k) clearances |
| Jun 23, 2023 | MapRTK231185 · IYE | 510(k) clearances |
| Nov 10, 2021 | AlignRT PlusK212583 · IYE | 510(k) clearances |
| Mar 4, 2021 | AlignRT PlusK203387 · IYE | 510(k) clearances |
| Jan 3, 2020 | AlignRT PlusK193431 · IYE | 510(k) clearances |
| Aug 7, 2018 | AlignRT PlusK181218 · IYE | 510(k) clearances |
| Nov 11, 2014 | AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before andClass II · Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened. | Device recalls |
| Oct 15, 2014 | AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precisioClass II · Potential failure of AlignRT to assert interlock. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
