FDA 510(k) clearance · back to tracker

Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty, Ltd. cleared K243955 on 2025-01-21, decision: substantially equivalent

K-number

K243955

Sponsor

Precision AI Pty, Ltd.

Device

Precision AI Surgical Planning System (PAI-SPS)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-01-21

Product code

QHE

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3660

Official FDA record

Open K243955on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.