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FDA 510(k)

Precision AI Surgical Planning System (PAI-SPS)

K-Number: K233992 · 2024-08-05

ApplicantPrecision AI Pty, Ltd.
Decision Date2024-08-05
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 2024-08-05 under approval number K233992. 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 2024-08-05. It is manufactured by Precision AI Pty, Ltd.. The 510(k) number is K233992.

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 2024-08-05, under approval number K233992.

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: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41543479 Ethical and Regulatory Considerations for Artificial Intelligence Adoption in Craniofacial Surgery. The Journal of craniofacial surgery ()

Other Devices by Precision AI Pty, Ltd.

K243955Precision AI Surgical Planning System (PAI-SPS) K251558Precision 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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