Precision AI Surgical Planning System (PAI-SPS)— 510(k) K243955

Name: FDA 510(k) clearance K243955
Creator: U.S. Food and Drug Administration
Published: 2025-01-21

Substantially Equivalent

Precision AI Pty, Ltd.

FDA 510(k) clearance K243955 for Precision AI Surgical Planning System (PAI-SPS), Substantially Equivalent on 2025-01-21. Applicant: Precision AI Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Precision AI Pty, Ltd.
Product code: Code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2024-12-23
Decision date: 2025-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Fortitude Valley, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.