ART.1-US— 510(k) K253078
Substantially EquivalentSeetreat Pty, Ltd.
FDA 510(k) clearance K253078 for ART.1-US, Substantially Equivalent on 2026-05-14. Applicant: Seetreat Pty, Ltd.. Device class: 2.
Summary
Seetreat filed ART.1-US under MUJ, radiation therapy treatment planning systems. The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Seetreat filed from Sydney, Australia. Review took 233 calendar days (September 23, 2025 to May 14, 2026).
Clearance details
- Applicant
- Seetreat Pty, Ltd.
- Product code
- Product code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sydney, AU
Recent devices under product code MUJ
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