Precision AI Pty, Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Precision AI Pty, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Precision AI Surgical Planning System (PAI-SPS), Precision AI Surgical Planning System (PAI-SPS), Precision AI Surgical Planning System (PAI-SPS)
3
Total
3
Cleared
0
Denied
Precision AI Pty, Ltd. has 3 FDA 510(k) cleared medical devices. Based in Fortitude Valley, AU.
Latest FDA clearance: Jan 2026. Active since 2024. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Precision AI Pty, Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Stefanie Michele Auf Der Mauer Asmuss as regulatory consultant.
FDA 510(k) Regulatory Record - Precision AI Pty, Ltd.
3 devices