# K253078: ART.1-US

- Pathway: 510(k) (Traditional)
- Applicant: Seetreat Pty, Ltd.
- Decided: May 14, 2026 after 233 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 19 generations back to K954874 (1996). 225 ancestors in all.
No later device cites it as a predicate yet.
1 of 226 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232479: ART-Plan, Therapanacea (2023) Summary page 7.

## Indications for use
ART.1-US is a software as a medical device intended to support the treatment re-plan process for cancer patients receiving radiation therapy. ART.1-US calculates delivered dose and contours based on cancer patients’ daily volumetric images, in addition to displaying and reporting relevant metrics. ART.1-US allows for the comparison of dosimetry between the delivery of each fraction and the treatment plan in radiation oncology. ART.1-US is intended for use by trained medical professionals as a decision support tool to aid the treatment re-plan process. ART.1-US is indicated for adult Head & Neck cancer patients undergoing radiation therapy.

Source page: https://510kreport.com/device/K253078
Methodology: https://510kreport.com/methodology