# K052682: Alignrt

- Pathway: 510(k) (Traditional)
- Applicant: Vision RT Limited
- Decided: Jan 6, 2006 after 100 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981153 (1999). 2 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983660: Exactrac (Brainlab Patient Positioning System), Brainlab, Inc. (1999) Summary page 1.
- K981153: Osiris, Huestis Medical (1999) Summary page 1.

## Most influential descendants
- K072171: Gatect-RT (2007), 12 descendants of its own
- K123371: Alignrt Plus (2013), 8 descendants of its own
- 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

## Recalls of this device
- Nov 11, 2014 · Class II · Z-0934-2015: Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.

## Indications for use
The AlignRT system is used to position patients undergoing external beam radiation therapy. Prior to each treatment session the patient is registered to the position which best reproduces the patient's position during treatment simulation. The system can also monitor the patient's position during treatment so that movements from the optimum position can be detected. Patient contour data can be extracted and exported from the acquired data for the purpose of treatment planning by radiotherapy professionals. AlignRT is used by radiotherapy professionals in appropriate hospital environments. It can be used with all types of radiotherapy patients and can image any visible anatomical region.

Source page: https://510kreport.com/device/K052682
Methodology: https://510kreport.com/methodology