# K253012: AlignRT Plus (8.0)

- Pathway: 510(k) (Traditional)
- Applicant: Vision Rt, Ltd.
- Decided: Mar 18, 2026 after 180 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K864886 (1987). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233622: AlignRT Plus, Vision Rt, Ltd. (2024) Summary page 5.

## Indications for use
The AlignRT Plus system is indicated for: * Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep- Inspiration Breath Hold (DIBH). * Verification of patient identity for their radiation treatment session. * Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment isocenter. * Withholding the beam automatically during radiation delivery, as well as gating the beam based on the patient's respiratory motion. * Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch. * Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient. * Passing and receiving information to/from other systems associated with the radiotherapy treatment.

Source page: https://510kreport.com/device/K253012
Methodology: https://510kreport.com/methodology