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 Rayence Co., Ltd., Canon, Inc. and Iray Technology Taicang , Ltd..

424
Total
424
Cleared
81d
Avg days
1997
Since
424 devices
121–144 of 424
Cleared Dec 18, 2018
SKR 3000
K182688
Konica Minolta, Inc.
Radiology · 83d
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 Nov 17, 2017
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
K171270
Canon, Inc.
Radiology · 200d
Cleared Jun 30, 2017
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
K163624
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 190d
Cleared Jun 12, 2017
1417WGC_127um and 1417WGC_140um
K171417
Rayence Co., Ltd.
Radiology · 28d
Cleared Jun 12, 2017
1417WCC_127um and1417WCC_140um
K171418
Rayence Co., Ltd.
Radiology · 28d
Cleared Jun 09, 2017
1717SGC_127um and 1717SGC_140um
K171419
Rayence Co., Ltd.
Radiology · 25d
Cleared Jun 09, 2017
1717SCC_127um and 1717SCC_140um
K171420
Rayence Co., Ltd.
Radiology · 25d
Cleared Mar 01, 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332
Canon, Inc.
Radiology · 27d
Cleared Oct 06, 2016
1012WCC, 1012WGC
K162518
Rayence Co., Ltd.
Radiology · 27d