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
Dec 22, 2015
Philips Eleva Workspot with SkyFlow
Philips Medical Systems Dmc GmbH
Radiology
34d
Cleared
Dec 21, 2015
GR40CW
Samsung Electronics Co., Ltd.
Radiology
27d
Cleared
Dec 11, 2015
DR 600
Agfa Healthcare N.V.
Radiology
87d
Cleared
Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
Carestream Health, Inc.
Radiology
26d
Cleared
Nov 10, 2015
ATAL 9
Atlaim Corporation
Radiology
99d
Cleared
Nov 10, 2015
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
Careray Digital Medical System Co., Ltd.
Radiology
20d
Cleared
Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
Fujifilm Medical System U.S.A., Inc.
Radiology
97d
Cleared
Oct 21, 2015
EVS 3643
DRTECH Corporation
Radiology
99d
Cleared
Oct 16, 2015
GR40CW
Samsung Electronics Co., Ltd.
Radiology
80d
Cleared
Sep 10, 2015
ViZion DR + Wireless
Viztek, LLC
Radiology
29d
Cleared
Sep 08, 2015
CAREVIEW 1800R
Careray Digital Medical System Co., Ltd.
Radiology
460d
Cleared
Aug 04, 2015
CareView 1500Cw X-ray Flat Panel Detectors
Careray Digital Medical System Co., Ltd.
Radiology
120d
Cleared
Jul 13, 2015
Aura DR 43C-AG flat panel detector
Abyzr Co., Ltd.
Radiology
88d
Cleared
Jun 29, 2015
AeroDR SYSTEM 2
Konica Minolta, Inc.
Radiology
28d
Cleared
Jun 24, 2015
Carestream DRX-1 System
Carestream Health, Inc.
Radiology
92d
Cleared
Jun 23, 2015
Kubtec DIGIVIEW 395
Kub Technologies, Inc.
Radiology
47d
Cleared
Mar 27, 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
Rayence Co., Ltd.
Radiology
63d
Cleared
Jan 30, 2015
Universal Digital Interface 2W, UDI 2W
Meridian Medical Systems, LLC
Radiology
81d
Cleared
Jan 23, 2015
RIS500
Ray Co., Ltd.
Radiology
98d
Cleared
Jan 15, 2015
EVS 4343
DRTECH Corporation
Radiology
134d
Cleared
Dec 17, 2014
Radlink GPS
Radlink, Inc.
Radiology
85d
Cleared
Oct 23, 2014
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
Perkinelmer, Inc.
Radiology
31d
Cleared
Oct 22, 2014
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
Meridian Medical Systems, LLC
Radiology
264d
Cleared
Oct 21, 2014
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
Fujifilm Medical System U.S.A., Inc.
Radiology
90d