FDA Product Code NEU: Marker, Radiographic, Implantable

Under FDA product code NEU, implantable radiographic markers are cleared for use in surgical and radiation oncology procedures.

These small metal clips or seeds are placed at the margins of surgical excision sites or tumor beds to provide a permanent radiographic landmark visible on X-ray, CT, and fluoroscopy for post-operative radiation targeting, surveillance imaging, and repeat surgery planning.

NEU devices are Class II medical devices, regulated under 21 CFR 878.4300 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Devicor Medical Products, Inc., Senorx, Inc. and Somatex Medical Technologies GmbH.