Extremity CT Imaging System— 510(k) K252249

Name: FDA 510(k) clearance K252249
Creator: U.S. Food and Drug Administration
Published: 2026-03-13

Substantially Equivalent

Mars Bioimaging , Ltd.

FDA 510(k) clearance K252249 for Extremity CT Imaging System, Substantially Equivalent on 2026-03-13. Applicant: Mars Bioimaging , Ltd.. Device class: 2.

Summary

Mars Bioimaging's Extremity CT Imaging System is filed under JAK, computed tomography x-ray systems. The name is generic, and the record doesn't give a model number.

Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).

Mars Bioimaging filed from Christchurch, New Zealand. The decision came 238 calendar days after receipt (July 18, 2025 to March 13, 2026).

Clearance details

Applicant: Mars Bioimaging , Ltd.
Product code: Product code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2025-07-18
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Christchurch, NZ

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.