# K212583: AlignRT Plus

- Pathway: 510(k) (Traditional)
- Applicant: Vision Rt, Ltd.
- Decided: Nov 10, 2021 after 86 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: 8 generations back to K864886 (1987). 11 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K203387: AlignRT Plus, Vision Rt, Ltd. (2021) Summary page 4.

## Most influential descendants
- K233622: AlignRT Plus (2024), 2 descendants of its own
- K253004: LUNA 3D (2026), 0 descendants of its own
- K253012: AlignRT Plus (8.0) (2026), 0 descendants of its own
- K232031: LUNA 3D (2024), 0 descendants of its own

## 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 head adjuster is included which can be used in concert with AlignRT 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/K212583
Methodology: https://510kreport.com/methodology