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ART.1-US

by SeeTreat Pty Ltd

510(k) K253078

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253078↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253078 Date14 May 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253078 decided 14 May 2026 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
MUJ
FDA applicant
Seetreat Pty, Ltd.
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Similar devices

Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).

Other devices from SeeTreat Pty Ltd

  • ART.1

    Class IIa