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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 a medical device manufactured by Precision AI Pty, Ltd.. It received FDA 510(k) clearance on 2026-01-12 under approval 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. It is manufactured by Precision AI Pty, Ltd.. The 510(k) number is K251558.

When was Precision AI Surgical Planning System (PAI-SPS) approved by the FDA?

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

What company makes Precision AI Surgical Planning System (PAI-SPS)?

Precision AI Surgical Planning System (PAI-SPS) is manufactured by Precision AI Pty, Ltd..

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.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41543479 Ethical and Regulatory Considerations for Artificial Intelligence Adoption in Craniofacial Surgery. The Journal of craniofacial surgery () PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Precision AI Pty, Ltd.

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

Related Devices (Code: QHE)

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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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