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Precision AI Pty, Ltd.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K251558
Precision AI Surgical Planning System (PAI-SPS)
January 12, 2026
K243955
Precision AI Surgical Planning System (PAI-SPS)
January 21, 2025
K233992
Precision AI Surgical Planning System (PAI-SPS)
August 5, 2024