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
193–216 of 424
Cleared Dec 22, 2015
Philips Eleva Workspot with SkyFlow
K153318
Philips Medical Systems Dmc GmbH
Radiology · 34d
Cleared Dec 21, 2015
GR40CW
K153401
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Dec 11, 2015
DR 600
K152639
Agfa Healthcare N.V.
Radiology · 87d
Cleared Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
K153142
Carestream Health, Inc.
Radiology · 26d
Cleared Nov 10, 2015
ATAL 9
K152151
Atlaim Corporation
Radiology · 99d
Cleared Nov 10, 2015
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
K153058
Careray Digital Medical System Co., Ltd.
Radiology · 20d
Cleared Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
K152138
Fujifilm Medical System U.S.A., Inc.
Radiology · 97d
Cleared Oct 21, 2015
EVS 3643
K151942
DRTECH Corporation
Radiology · 99d
Cleared Oct 16, 2015
GR40CW
K152094
Samsung Electronics Co., Ltd.
Radiology · 80d
Cleared Sep 10, 2015
ViZion DR + Wireless
K152279
Viztek, LLC
Radiology · 29d
Cleared Sep 08, 2015
CAREVIEW 1800R
K141488
Careray Digital Medical System Co., Ltd.
Radiology · 460d
Cleared Aug 04, 2015
CareView 1500Cw X-ray Flat Panel Detectors
K150929
Careray Digital Medical System Co., Ltd.
Radiology · 120d
Cleared Jul 13, 2015
Aura DR 43C-AG flat panel detector
K151014
Abyzr Co., Ltd.
Radiology · 88d
Cleared Jun 29, 2015
AeroDR SYSTEM 2
K151465
Konica Minolta, Inc.
Radiology · 28d
Cleared Jun 24, 2015
Carestream DRX-1 System
K150766
Carestream Health, Inc.
Radiology · 92d
Cleared Jun 23, 2015
Kubtec DIGIVIEW 395
K151221
Kub Technologies, Inc.
Radiology · 47d
Cleared Mar 27, 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K150150
Rayence Co., Ltd.
Radiology · 63d
Cleared Jan 30, 2015
Universal Digital Interface 2W, UDI 2W
K143232
Meridian Medical Systems, LLC
Radiology · 81d
Cleared Jan 23, 2015
RIS500
K143000
Ray Co., Ltd.
Radiology · 98d
Cleared Jan 15, 2015
EVS 4343
K142475
DRTECH Corporation
Radiology · 134d
Cleared Dec 17, 2014
Radlink GPS
K142718
Radlink, Inc.
Radiology · 85d
Cleared Oct 23, 2014
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
K142698
Perkinelmer, Inc.
Radiology · 31d
Cleared Oct 22, 2014
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
K140251
Meridian Medical Systems, LLC
Radiology · 264d
Cleared Oct 21, 2014
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
K142003
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d