FDA Product Code MQB: Solid State X-ray Imager (flat Panel/digital Imager)
FDA product code MQB covers solid-state X-ray imagers, also known as flat panel detectors or digital image receptors.
These devices replace traditional film and computed radiography cassettes with direct digital capture of X-ray images. They provide higher image quality, lower radiation dose, and immediate image availability compared to conventional systems.
MQB devices are Class II medical devices, regulated under 21 CFR 892.1680 and reviewed by the FDA Radiology panel.
Leading manufacturers include Canon, Inc., Iray Technology Taicang , Ltd. and Lg Electronics.Inc.
List of Solid State X-ray Imager (flat Panel/digital Imager) devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Solid State X-ray Imager (flat Panel/digital Imager) devices (product code MQB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →