FDA 510(k)

ART.1-US

K-Number: K253078 · 2026-05-14

Decision Date2026-05-14

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ART.1-US is the device name listed in this FDA 510(k) record. The listed applicant is Seetreat Pty, Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K253078. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ART.1-US?

ART.1-US is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Seetreat Pty, Ltd.. The 510(k) number is K253078.

When did ART.1-US receive FDA 510(k) clearance?

ART.1-US received FDA 510(k) clearance on 2026-05-14, under 510(k) number K253078.

Who is the listed applicant for ART.1-US?

The FDA 510(k) record lists Seetreat Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ART.1-US?

The FDA product code for ART.1-US is MUJ.

Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformai K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.K260308TrueFit BolusAdaptiiv Medical Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.