FDA 510(k)

Extremity CT Imaging System

K-Number: K252249 · 2026-03-13

Decision Date2026-03-13

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Extremity CT Imaging System is a medical device manufactured by Mars Bioimaging , Ltd.. It received FDA 510(k) clearance on 2026-03-13 under approval number K252249. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extremity CT Imaging System?

Extremity CT Imaging System is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Mars Bioimaging , Ltd.. The 510(k) number is K252249.

When was Extremity CT Imaging System approved by the FDA?

Extremity CT Imaging System received FDA 510(k) clearance on 2026-03-13, under approval number K252249.

What company makes Extremity CT Imaging System?

Extremity CT Imaging System is manufactured by Mars Bioimaging , Ltd..

What is the FDA product code for Extremity CT Imaging System?

The FDA product code for Extremity CT Imaging System is JAK.

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Related PubMed Literature

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)

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Official Source

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