Precision AI Surgical Planning System (PAI-SPS)— 510(k) K251558

Name: FDA 510(k) clearance K251558
Creator: U.S. Food and Drug Administration
Published: 2026-01-12

Substantially Equivalent

Precision AI Pty, Ltd.

FDA 510(k) clearance K251558 for Precision AI Surgical Planning System (PAI-SPS), Substantially Equivalent on 2026-01-12. 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: 2025-05-21
Decision date: 2026-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fortitude Valley, AU

Download summary PDF View on FDA.gov ↗

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K243509 — Archer PSI System2025-05-12
K241470 — CORE Shoulder System2025-02-20

More clearances from Precision AI Pty, Ltd.

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K243955 — Precision AI Surgical Planning System (PAI-SPS)2025-01-21
K233992 — Precision AI Surgical Planning System (PAI-SPS)2024-08-05

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