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
Jan 31, 2020
HAD1717MC
H&Abyz
Radiology
28d
Cleared
Dec 20, 2019
Nexus DR Digital X-Ray Imaging System (with vSharp)
Varex Imaging Corporation
Radiology
25d
Cleared
Dec 13, 2019
CareView 1800Le
Careray Digital Medical System Co., Ltd.
Radiology
25d
Cleared
Nov 22, 2019
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
DRTECH Corporation
Radiology
24d
Cleared
Nov 22, 2019
EXPD 4343P, EXPD 3643P
DRTECH Corporation
Radiology
23d
Cleared
Nov 12, 2019
FDR D-EVO III flat panel detector system
Fujifilm Corporation
Radiology
26d
Cleared
Nov 07, 2019
DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
Canon, Inc.
Radiology
45d
Cleared
Nov 01, 2019
FDR SE Lite
Fujifilm Corporation
Radiology
56d
Cleared
Oct 16, 2019
Focus 35C Detector, Trimax 35C Detector
Iray Technology Taicang , Ltd.
Radiology
34d
Cleared
Oct 03, 2019
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
DRTECH Corporation
Radiology
30d
Cleared
Aug 29, 2019
Yushan X-Ray Flat Panel Detector
Innocare Optoelectronics Corp.
Radiology
41d
Cleared
Aug 16, 2019
SKR 4000
Konica Minolta, Inc.
Radiology
58d
Cleared
Apr 08, 2019
VIVIX-S 1751S
Vieworks Co., Ltd.
Radiology
28d
Cleared
Apr 04, 2019
Pixx2430 Digital Diagnostic X-Ray Receptor Panel
Pixxgen Corporation
Radiology
17d
Cleared
Mar 13, 2019
BIOK7600W Wireless Flat Panel Detector
Biokinemetrics, Inc.
Radiology
29d
Cleared
Mar 13, 2019
BIOK7600 Flat Panel Detector
Biokinemetrics, Inc.
Radiology
29d
Cleared
Mar 13, 2019
Enhanced Feature Software Pack CXDI Series
Canon, Inc.
Radiology
26d
Cleared
Mar 08, 2019
Nexus DR Digital X-ray Imaging System
Varex Imaging Corporation
Radiology
38d
Cleared
Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
Carestream Health, Inc.
Radiology
79d
Cleared
Jan 16, 2019
Carestream DRX-1 System with DRX Core Detectors
Carestream Health, Inc.
Radiology
30d
Cleared
Jan 11, 2019
DigitalDiagnost C90
Philips Medical Systems Dmc GmbH
Radiology
77d
Cleared
Jan 09, 2019
Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
30d
Cleared
Jan 09, 2019
Wireless Digital Flat Detector
Iray Technology Taicang , Ltd.
Radiology
30d
Cleared
Dec 18, 2018
SKR 3000
Konica Minolta, Inc.
Radiology
83d