FDA 510(k) clearance · back to tracker

Extremity CT Imaging System

Mars Bioimaging , Ltd. cleared K252249 on 2026-03-13, decision: substantially equivalent

K-number

K252249

Sponsor

Mars Bioimaging , Ltd.

Device

Extremity CT Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-03-13

Product code

JAK

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1750

Official FDA record

Open K252249on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.