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MRI Marker

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131689

by C4 Imaging, LLC

Identifiers

510(k) Number
K131689 FDA 510(k)
FDA Product Code
KXK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5730 FDA 510(k)
Regulation Number
892.5730 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An MRI Marker is a device used as a source in brachytherapy radionuclide applications. It is designed to be visible under MRI imaging to assist in localization and treatment planning.

The device is supplied non-sterile and is intended for reusable use. It is manufactured by C4 Imaging, LLC and has received FDA 510(k) clearance under K131689, with product code KXK and classification as a Class II device in the Radiology specialty.

Frequently asked questions

What is the MRI Marker used for?

The MRI Marker is used as a source in brachytherapy radionuclide applications. It is designed to be visible under MRI imaging to assist in localization and treatment planning, helping clinicians accurately target treatment areas during radiation therapy.

Is the MRI Marker sterile or non-sterile, and is it intended for single-use or reuse?

The MRI Marker is supplied non-sterile and is intended for reusable use. This means it must be cleaned and sterilized by the user before each application, and it is designed to withstand multiple uses over its lifecycle.

What regulatory clearance does the MRI Marker have, and under what number?

The MRI Marker has received FDA 510(k) clearance under submission number K131689. It was found substantially equivalent to a predicate device and is classified as a Class II device with product code KXK in the Radiology specialty.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: C4 Imaging, NOVA Product Page - c4imaging.com, C4 Imaging Announces Introduction of the Nova Z Fiducial Marker, C4 Imaging - LinkedIn, HDR MRI Lumen Marker - MedEquip Directory

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C4 Imaging, LLC

Sources (1)

  • FDA 510(k) K131689 24 fields · synced Sep 22, 2026