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

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..

Clearance details

Applicant: Precision AI Pty, Ltd.
Product code: Code QHE
Advisory panel: Orthopedic
Date received: 2025-05-21
Decision date: 2026-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fortitude Valley, AU

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