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 Iray Technology Taicang , Ltd., Canon, Inc. and DRTECH Corporation.
421
Total
421
Cleared
80d
Avg days
1997
Since
421 devices
Cleared
Dec 07, 2018
Nexus DR Digital X-ray Imaging System with stitching
Varex Imaging Corporation
Radiology
18d
Cleared
Dec 07, 2018
17HK701G-W
Lg Electronics.Inc
Radiology
11d
Cleared
Oct 18, 2018
14HK701G-W
Lg Electronics.Inc
Radiology
50d
Cleared
Oct 17, 2018
Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
30d
Cleared
Oct 17, 2018
Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
30d
Cleared
Oct 04, 2018
PIXX 1717
Pixxgen Corporation
Radiology
20d
Cleared
Jul 20, 2018
GR40CW
Samsung Electronics Co., Ltd.
Radiology
30d
Cleared
Jul 13, 2018
Aquarius 8600 Digital Radiography Sensor
Biokinemetrics, Inc.
Radiology
29d
Cleared
Jul 03, 2018
XRpad2 4343 HWC-M Flat Panel Detector
Varex Imaging Corporation
Radiology
22d
Cleared
Jun 21, 2018
Eclipse II
Carestream Health, Inc.
Radiology
85d
Cleared
Jun 13, 2018
PEDRA-17F Digital Flat Panel X-ray Detector
Radisen, Inc.
Radiology
58d
Cleared
Jun 08, 2018
17HK700G-W
Lg Electronics
Radiology
122d
Cleared
May 24, 2018
PIXX 1717
Pixxgen Corporation
Radiology
41d
Cleared
May 15, 2018
VIVIX-S 1717V
Vieworks Co., Ltd.
Radiology
29d
Cleared
Apr 13, 2018
SmartGrid
Carestream Health, Inc.
Radiology
30d
Cleared
May 09, 2006
AXIOM ARISTOS FX PLUS
Siemens Medical Solutions USA, Inc.
Radiology
22d
Cleared
Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
Eastman Kodak Company
Radiology
56d
Cleared
Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
Eastman Kodak Company
Radiology
15d
Cleared
Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
Eastman Kodak Company
Radiology
28d
Cleared
Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
Eastman Kodak Company
Radiology
22d
Cleared
Apr 21, 1999
THORAX FD AND MULTIX FD
Siemens Medical Solutions USA, Inc.
Radiology
181d