K253078
- 510(k) number
- K253078
- Device name
- ART.1-US
- Applicant
- Seetreat Pty, Ltd. AU
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2026-05-14
- Date received
- 2025-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253078.pdf
Official FDA record: K253078
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.