MQB · Class II · 21 CFR 892.1680

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
121–144 of 421
Cleared Dec 07, 2018
Nexus DR Digital X-ray Imaging System with stitching
K183212
Varex Imaging Corporation
Radiology · 18d
Cleared Dec 07, 2018
17HK701G-W
K183286
Lg Electronics.Inc
Radiology · 11d
Cleared Oct 18, 2018
14HK701G-W
K182348
Lg Electronics.Inc
Radiology · 50d
Cleared Oct 17, 2018
Wireless Digital Flat Panel Detector
K182550
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Oct 17, 2018
Wireless Digital Flat Panel Detector
K182551
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Oct 04, 2018
PIXX 1717
K182533
Pixxgen Corporation
Radiology · 20d
Cleared Jul 20, 2018
GR40CW
K181631
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 13, 2018
Aquarius 8600 Digital Radiography Sensor
K181565
Biokinemetrics, Inc.
Radiology · 29d
Cleared Jul 03, 2018
XRpad2 4343 HWC-M Flat Panel Detector
K181526
Varex Imaging Corporation
Radiology · 22d
Cleared Jun 21, 2018
Eclipse II
K180809
Carestream Health, Inc.
Radiology · 85d
Cleared Jun 13, 2018
PEDRA-17F Digital Flat Panel X-ray Detector
K180989
Radisen, Inc.
Radiology · 58d
Cleared Jun 08, 2018
17HK700G-W
K180332
Lg Electronics
Radiology · 122d
Cleared May 24, 2018
PIXX 1717
K180976
Pixxgen Corporation
Radiology · 41d
Cleared May 15, 2018
VIVIX-S 1717V
K181003
Vieworks Co., Ltd.
Radiology · 29d
Cleared Apr 13, 2018
SmartGrid
K180667
Carestream Health, Inc.
Radiology · 30d
Cleared May 09, 2006
AXIOM ARISTOS FX PLUS
K061054
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K060137
Eastman Kodak Company
Radiology · 56d
Cleared Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483
Eastman Kodak Company
Radiology · 15d
Cleared Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829
Eastman Kodak Company
Radiology · 28d
Cleared Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
K020635
Eastman Kodak Company
Radiology · 22d
Cleared Apr 21, 1999
THORAX FD AND MULTIX FD
K983732
Siemens Medical Solutions USA, Inc.
Radiology · 181d