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
169–192 of 424
Cleared Jan 27, 2017
CSX-30 Flat Panel Detector
K162909
Canon Inc. -Medical Equipment Group
Radiology · 102d
Cleared Dec 21, 2016
EVS 4343, EVS 4343G
K162555
DRTECH Corporation
Radiology · 99d
Cleared Dec 20, 2016
INNOLUX RIC
K162344
Innolux Corporation
Radiology · 120d
Cleared Dec 08, 2016
Wireless Digital Flat Panel Detector
K161730
Iray Technology (Shanghai) , Ltd.
Radiology · 168d
Cleared Dec 02, 2016
EVS 3643, EVS 3643G
K162552
DRTECH Corporation
Radiology · 80d
Cleared Dec 01, 2016
CareView 750Cw/750C X-ray Flat Panel Detectors
K163019
Careray Digital Medical System Co., Ltd.
Radiology · 31d
Cleared Oct 28, 2016
ClearVision ExamVue Flat Panel Detector
K160143
Jpi Healthcare, Inc.
Radiology · 281d
Cleared Oct 14, 2016
BSD3543 Digital Flat Panel X-ray Detector
K162487
Bontech, Inc.
Radiology · 37d
Cleared Oct 06, 2016
1012WCC, 1012WGC
K162518
Rayence Co., Ltd.
Radiology · 27d
Cleared Oct 06, 2016
1717WCC / 1717WGC
K162519
Rayence Co., Ltd.
Radiology · 27d
Cleared Oct 03, 2016
SKR 3000
K162504
Konica Minolta, Inc.
Radiology · 26d
Cleared Sep 22, 2016
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
K161368
Agfa Healthcare N.V.
Radiology · 128d
Cleared Sep 08, 2016
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
K161966
Perkinelmer, Inc.
Radiology · 52d
Cleared Sep 06, 2016
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
K161459
Varian Medical Systems, X-Ray Products-Infimed
Radiology · 103d
Cleared Sep 01, 2016
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
K161942
Perkinelmer, Inc.
Radiology · 48d
Cleared Sep 01, 2016
CareView 1500P X-ray Flat Panel Detectors
K162178
Careray Digital Medical System Co., Ltd.
Radiology · 28d
Cleared Jun 28, 2016
SCATTER CORRECTION FOR CXDI SERIES
K153312
Canon, Inc.
Radiology · 224d
Cleared Jun 09, 2016
BSD4343 Digital Flat Panel X-ray Detector
K160204
Bontech, Inc.
Radiology · 133d
Cleared May 20, 2016
ViZion DR + Wireless
K160810
Viztek, LLC
Radiology · 57d
Cleared Apr 08, 2016
FDR D-EVO flat Panel Detector System
K153464
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 129d
Cleared Mar 18, 2016
Tuxedo Digital Dental Sensor
K153710
Led Dental, Inc.
Radiology · 85d
Cleared Feb 26, 2016
VIVIX-S 1012N
K152855
Vieworks Co., Ltd.
Radiology · 150d
Cleared Feb 26, 2016
VIVIX-S 1717N
K152894
Vieworks Co., Ltd.
Radiology · 149d
Cleared Dec 24, 2015
CareView 1800L
K153492
Careray Digital Medical System Co., Ltd.
Radiology · 20d