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ART.1-US

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253078

by SeeTreat Pty Ltd

Identifiers

510(k) Number
K253078 FDA 510(k)
FDA Product Code
MUJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

What clinical workflows is the ART.1-US designed to integrate with, and how does it improve treatment accuracy in radiation oncology?

The ART.1-US is a software-based system specifically designed to enhance radiation therapy planning and treatment workflows by providing advanced computational tools. It optimizes radiation dose delivery to precisely target tumors while minimizing exposure to surrounding healthy tissue, thereby improving treatment accuracy and efficiency. Since it operates as a standalone solution, it can be seamlessly integrated into existing clinical infrastructure without requiring additional hardware.

Is the ART.1-US a single-use or reusable device, and what are its storage requirements?

The ART.1-US is a reusable software-based tool, meaning it does not have single-use requirements. As a software solution, it does not require specific sterility measures or physical storage conditions beyond standard IT infrastructure requirements, such as secure, climate-controlled environments for servers or workstations where it is installed.

What regulatory pathways has the ART.1-US followed, and which advisory committee was involved in its review?

The ART.1-US has undergone regulatory review through the FDA’s 510(k) pathway and the EU Medical Device Regulation (MDR), both of which confirm its compliance with radiation therapy planning systems. The device was reviewed by the Radiology (RA) Advisory Committee under the FDA’s Traditional 510(k) Review process, with a decision of Substantially Equivalent (SESE) granted on May 14, 2026.

Does the ART.1-US require any additional hardware to function, and how does it adapt to existing clinical settings?

No, the ART.1-US is a standalone software solution that does not require additional hardware beyond standard IT systems already present in clinical settings. Its design allows it to integrate directly into existing workflows, making it adaptable to a wide range of radiation oncology environments without requiring specialized equipment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
SeeTreat Pty Ltd
FDA Applicant
Seetreat Pty, Ltd.

Sources (2)

  • FDA 510(k) K253078 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026