Clearance Summary
Precision AI Surgical Planning System (PAI-SPS) received FDA 510(k) clearance under submission number K243955, sponsored by Precision AI Pty, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-01-21.
- Submission: K243955
- Applicant / Sponsor: Precision AI Pty, Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2025-01-21
Classification & Regulation
This clearance is catalogued under FDA product code QHE and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.