| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-01-12 | K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | Orthopedic |
| 2025-01-21 | K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | Orthopedic |
| 2024-08-05 | K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | Orthopedic |