Cleared Traditional

Extremity CT Imaging System

K252249 · Mars Bioimaging , Ltd. · Radiology

Mar 2026

Decision

238d

Days

Class 2

Risk

About This 510(k) Submission

K252249 is an FDA 510(k) clearance for the Extremity CT Imaging System, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Mars Bioimaging , Ltd. (Christchurch, NZ). The FDA issued a Cleared decision on March 13, 2026, 238 days after receiving the submission on July 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K252249 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2025
Decision Date	March 13, 2026
Days to Decision	238 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF