# K123371: Alignrt Plus

- Pathway: 510(k) (Traditional)
- Applicant: Vision RT Limited
- Decided: Jan 8, 2013 after 68 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864886 (1987). 7 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052682: Alignrt, Vision RT Limited (2006) Summary page 1.
- K072171: Gatect-RT, Vision RT Limited (2007) Summary page 1.

## Most influential descendants
- K181218: AlignRT Plus (2018), 7 descendants of its own
- K193431: AlignRT Plus (2020), 6 descendants of its own
- K203387: AlignRT Plus (2021), 5 descendants of its own
- K212583: AlignRT Plus (2021), 4 descendants of its own
- K233622: AlignRT Plus (2024), 2 descendants of its own

## Recalls of this device
- Aug 24, 2018 · Class II · Z-0065-2019: RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
- Jun 30, 2016 · Class II · Z-2667-2016: Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, 
- Jun 23, 2016 · Class II · Z-2149-2016: Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user 
- Jun 23, 2016 · Class II · Z-2150-2016: Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user 
- Oct 15, 2014 · Class II · Z-0464-2015: Potential failure of AlignRT to assert interlock.

## Indications for use
The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual bead adjuster is included which can be used in concert wit AlignkT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on.MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

Source page: https://510kreport.com/device/K123371
Methodology: https://510kreport.com/methodology