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FDA 510(k)

Precision AI Surgical Planning System (PAI-SPS)

K-Number: K251558 · 2026-01-12

ApplicantPrecision AI Pty, Ltd.
Decision Date2026-01-12
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precision AI Surgical Planning System (PAI-SPS) is the device name listed in this FDA 510(k) record. The listed applicant is Precision AI Pty, Ltd.. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K251558. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision AI Surgical Planning System (PAI-SPS)?

Precision AI Surgical Planning System (PAI-SPS) is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Precision AI Pty, Ltd.. The 510(k) number is K251558.

When did Precision AI Surgical Planning System (PAI-SPS) receive FDA 510(k) clearance?

Precision AI Surgical Planning System (PAI-SPS) received FDA 510(k) clearance on 2026-01-12, under 510(k) number K251558.

Who is the listed applicant for Precision AI Surgical Planning System (PAI-SPS)?

The FDA 510(k) record lists Precision AI Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision AI Surgical Planning System (PAI-SPS)?

The FDA product code for Precision AI Surgical Planning System (PAI-SPS) is QHE.

Other records listing Precision AI Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243955Precision AI Surgical Planning System (PAI-SPS)K233992Precision AI Surgical Planning System (PAI-SPS)

Related Devices (Code: QHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NVK261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK243509Archer PSI System3D-SideK241470CORE Shoulder SystemLinkBio Corp.K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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