# K243301: MapRT

- Pathway: 510(k) (Traditional)
- Applicant: Vision Rt, Ltd.
- Decided: May 19, 2025 after 213 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: 15 generations back to K954874 (1996). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231185: MapRT, Vision Rt, Ltd. (2023) Summary page 5.

## Indications for use
MapRT is indicated for assisting with planning of radiation therapy by: - Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and - Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures

Source page: https://510kreport.com/device/K243301
Methodology: https://510kreport.com/methodology