510(k) K253078
K253078 is an FDA 510(k) premarket notification submitted by Seetreat Pty, Ltd. for the device "ART.1-US". The FDA issued a decision of Substantially Equivalent on May 14, 2026. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2026
- Date Received
- September 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type