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
97–120 of 421
Cleared Jan 31, 2020
HAD1717MC
K200018
H&Abyz
Radiology · 28d
Cleared Dec 20, 2019
Nexus DR Digital X-Ray Imaging System (with vSharp)
K193238
Varex Imaging Corporation
Radiology · 25d
Cleared Dec 13, 2019
CareView 1800Le
K193173
Careray Digital Medical System Co., Ltd.
Radiology · 25d
Cleared Nov 22, 2019
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
K193017
DRTECH Corporation
Radiology · 24d
Cleared Nov 22, 2019
EXPD 4343P, EXPD 3643P
K193031
DRTECH Corporation
Radiology · 23d
Cleared Nov 12, 2019
FDR D-EVO III flat panel detector system
K192932
Fujifilm Corporation
Radiology · 26d
Cleared Nov 07, 2019
DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
K192632
Canon, Inc.
Radiology · 45d
Cleared Nov 01, 2019
FDR SE Lite
K192440
Fujifilm Corporation
Radiology · 56d
Cleared Oct 16, 2019
Focus 35C Detector, Trimax 35C Detector
K192512
Iray Technology Taicang , Ltd.
Radiology · 34d
Cleared Oct 03, 2019
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
K192400
DRTECH Corporation
Radiology · 30d
Cleared Aug 29, 2019
Yushan X-Ray Flat Panel Detector
K191939
Innocare Optoelectronics Corp.
Radiology · 41d
Cleared Aug 16, 2019
SKR 4000
K191645
Konica Minolta, Inc.
Radiology · 58d
Cleared Apr 08, 2019
VIVIX-S 1751S
K190611
Vieworks Co., Ltd.
Radiology · 28d
Cleared Apr 04, 2019
Pixx2430 Digital Diagnostic X-Ray Receptor Panel
K190691
Pixxgen Corporation
Radiology · 17d
Cleared Mar 13, 2019
BIOK7600W Wireless Flat Panel Detector
K190300
Biokinemetrics, Inc.
Radiology · 29d
Cleared Mar 13, 2019
BIOK7600 Flat Panel Detector
K190311
Biokinemetrics, Inc.
Radiology · 29d
Cleared Mar 13, 2019
Enhanced Feature Software Pack CXDI Series
K190368
Canon, Inc.
Radiology · 26d
Cleared Mar 08, 2019
Nexus DR Digital X-ray Imaging System
K190146
Varex Imaging Corporation
Radiology · 38d
Cleared Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
K183245
Carestream Health, Inc.
Radiology · 79d
Cleared Jan 16, 2019
Carestream DRX-1 System with DRX Core Detectors
K183474
Carestream Health, Inc.
Radiology · 30d
Cleared Jan 11, 2019
DigitalDiagnost C90
K182973
Philips Medical Systems Dmc GmbH
Radiology · 77d
Cleared Jan 09, 2019
Wireless Digital Flat Panel Detector
K183422
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Jan 09, 2019
Wireless Digital Flat Detector
K183713
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Dec 18, 2018
SKR 3000
K182688
Konica Minolta, Inc.
Radiology · 83d