London, GB · 7 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IYE | — | — | — | 7 | 2026-03-18 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-08-27 | Class II | Ongoing | Z-0998-2026 | The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position… | — | Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-18 | K253012 | AlignRT Plus (8.0) | IYE | — | — |
| 2025-05-19 | K243301 | MapRT | IYE | — | — |
| 2024-03-29 | K233622 | AlignRT Plus | IYE | — | — |
| 2023-06-23 | K231185 | MapRT | IYE | — | — |
| 2021-11-10 | K212583 | AlignRT Plus | IYE | — | — |
| 2021-03-04 | K203387 | AlignRT Plus | IYE | — | — |
| 2020-01-03 | K193431 | AlignRT Plus | IYE | — | — |