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