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
145–168 of 424
Cleared Oct 12, 2017
Aquarius 8600 1417TG and Aquarius 8600 1717TG
K171169
Imaging Dynamics Company , Ltd.
Radiology · 174d
Cleared Oct 12, 2017
SKR 3000
K172793
Konica Minolta, Inc.
Radiology · 27d
Cleared Oct 06, 2017
Edge Air Digital Flat Panel X-ray Detector
K172681
Osko, Inc.
Radiology · 30d
Cleared Oct 06, 2017
Edge Digital Flat Panel X-ray Detector
K172682
Osko, Inc.
Radiology · 30d
Cleared Oct 05, 2017
Aquarius 8600 1417WC
K171175
Imaging Dynamics Company , Ltd.
Radiology · 167d
Cleared Sep 26, 2017
CareView 1800Cw X-ray Flat Panel Detectors
K172581
Careray Digital Medical System Co., Ltd.
Radiology · 29d
Cleared Aug 25, 2017
SKR 3000
K171716
Konica Minolta, Inc.
Radiology · 77d
Cleared Jul 07, 2017
Models 3543A, 4343A, 2929A and A843B
K170480
Shanghai PZ Medical Technolgoy Co., Ltd.
Radiology · 141d
Cleared Jul 07, 2017
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
K171461
Philips Medical Systems Dmc GmbH
Radiology · 50d
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 21, 2017
BSD4343R Digital Flat Panel X-ray Detector
K171485
Bontech, Inc.
Radiology · 30d
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 May 17, 2017
Nexus DR Digital X-ray Imaging System
K171138
Varex Imaging Corporation
Radiology · 29d
Cleared May 15, 2017
EVS 2430W, EVS 2430GW
K171137
DRTECH Corporation
Radiology · 28d
Cleared May 11, 2017
GMR40
K171085
Neurologica Corporation, A Subsidiary OF
Radiology · 29d
Cleared May 01, 2017
Televere Digital Imaging System
K170975
Televere Systems
Radiology · 28d
Cleared Mar 21, 2017
SmartGrid
K163157
Carestream Health
Radiology · 131d
Cleared Mar 01, 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332
Canon, Inc.
Radiology · 27d
Cleared Feb 22, 2017
Aquarius 8600
K170202
Imaging Dynamics Company , Ltd.
Radiology · 30d
Cleared Feb 09, 2017
pixium 4343RCE
K170113
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Feb 08, 2017
VIVIX-S 1417N
K163703
Vieworks Co., Ltd.
Radiology · 41d