# ART.1-US

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/art-1-us-muj>
- Manufacturer: [SeeTreat Pty Ltd](https://devicerts.com/manufacturers/seetreat-pty-ltd) (Australia)
- Device class: Class II (US FDA)
- FDA product code: MUJ

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The ART.1-US is a System, Planning, Radiation Therapy Treatment, designed for radiation oncology planning and treatment. It provides advanced computational tools to optimize radiation dose delivery, ensuring precise targeting of tumors while minimizing exposure to surrounding healthy tissue. This system integrates with existing workflows to enhance treatment accuracy and efficiency in radiotherapy.

Supplied as a software solution, the ART.1-US is intended for use in clinical settings by qualified radiation oncologists and treatment planners. It operates as a standalone system without requiring additional hardware, making it adaptable to existing infrastructure. The device is classified under FDA 510(k) clearance and MDR, adhering to regulatory standards for radiation therapy planning systems. No specific sterility or single-use requirements are noted, as it is a reusable software-based tool.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K253078 · decision 2026-05-14 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K253078 [FDA 510(k)]
- FDA product code: MUJ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.5050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: ART.1-US, SeeTreat Pty Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/art-1-us-muj (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/art-1-us-muj.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/art-1-us-muj
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.