Vision RT Ltd

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
7
Inspections
0
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0998-2026Class IIThe AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track thAugust 27, 2025
Z-0065-2019Class IIIntegrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is aAugust 24, 2018
Z-2667-2016Class IIAlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to positioJune 30, 2016
Z-2668-2016Class IITrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeaJune 30, 2016
Z-0934-2015Class IIAlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skNovember 11, 2014
Z-0464-2015Class IIAlignRT- Intended for prescription use. The system is indicated for use during simulation, setup anOctober 15, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K243301MapRTMay 19, 2025
K233622AlignRT PlusMarch 29, 2024
K231185MapRTJune 23, 2023
K212583AlignRT PlusNovember 10, 2021
K203387AlignRT PlusMarch 4, 2021
K193431AlignRT PlusJanuary 3, 2020
K181218AlignRT PlusAugust 7, 2018