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.
FDA 510(k) Cleared Solid State X-ray Imager (flat Panel/digital Imager) Devices (Product Code MQB)
About Product Code MQB - Regulatory Context
510(k) Submission Activity
421 total 510(k) submissions under product code MQB since 1997, with 421 receiving FDA clearance (average review time: 80 days).
Submission volume has declined in recent years - 14 submissions in the last 24 months compared to 30 in the prior period.
FDA Review Time
Recent submissions under MQB have taken an average of 133 days to reach a decision - up from 78 days historically. Manufacturers should account for longer review timelines in current project planning.
MQB devices are reviewed by the Radiology panel. Browse all Radiology devices →