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 DRTECH Corporation.
421
Total
421
Cleared
80d
Avg days
1997
Since
421 devices
Cleared
Apr 28, 2021
1717FCC
Rayence Co., Ltd.
Radiology
27d
Cleared
Apr 02, 2021
Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.
Radiology
219d
Cleared
Mar 03, 2021
Mars 1417X Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
28d
Cleared
Mar 02, 2021
Mars1717X Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
27d
Cleared
Jan 26, 2021
General Radiography CXDI-CS01
Canon, Inc.
Radiology
26d