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Extremity CT Imaging System

by Mars Bioimaging, Ltd.

510(k) K252249

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252249 Date13 Mar 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAK
FDA applicant
Mars Bioimaging , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Extremity CT Imaging System is an x-ray computed tomography imaging device designed for the upper extremities of adult patients. It utilizes spectral photon-counting CT technology to provide high-resolution imaging with material detection capabilities.

This device is intended for prescription use in professional healthcare environments by qualified and trained healthcare professionals. It has received FDA 510K clearance under the K252249 submission.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical application of the Extremity CT Imaging System?

    The Extremity CT Imaging System is designed specifically for imaging the upper extremities of adult patients. It utilizes spectral photon-counting CT technology to deliver high-resolution images that include material detection capabilities.

  • Who is authorized to operate this imaging system?

    This device is intended for prescription use only within professional healthcare environments. It must be operated exclusively by qualified and trained healthcare professionals to ensure safe and accurate imaging.

  • What is the regulatory status of this device?

    The Extremity CT Imaging System has received FDA 510K clearance under submission number K252249. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.