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
Oct 16, 2014
DX-D IMAGING PACKAGE
Agfa Healthcare N.V.
Radiology
69d
Cleared
Oct 03, 2014
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
Radiology Solutions, LLC
Radiology
95d
Cleared
Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
Fujifilm Medical Systems U.S.A, Inc.
Radiology
94d
Cleared
Sep 26, 2014
AERODR SYSTEM 2
Konica Minolta, Inc.
Radiology
134d
Cleared
Sep 12, 2014
DX-D IMAGING PACKAGE
Agfa Healthcare N.V.
Radiology
88d
Cleared
Aug 29, 2014
DICOMPACS DX-R WITH FLAT PANEL
Oehm Und Rehbein GmbH
Radiology
88d
Cleared
Aug 27, 2014
OPAL CHIRO, 20/20 P-DR
2020 Imaging
Radiology
89d
Cleared
Aug 01, 2014
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
Perkinelmer, Inc.
Radiology
150d
Cleared
Jul 25, 2014
PHILIPS PROGRADE
Philips Medical Systems Dmc GmbH
Radiology
28d
Cleared
Jul 17, 2014
DELWORKS DR SYSTEM
Del Medical, Inc.
Radiology
107d
Cleared
Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
Rayence Co., Ltd.
Radiology
34d
Cleared
Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
Rayence Co., Ltd.
Radiology
34d
Cleared
Jul 01, 2014
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
Canon, Inc.
Radiology
210d
Cleared
Jun 06, 2014
DR 400
Agfa Healthcare N.V.
Radiology
29d
Cleared
May 15, 2014
XGEO GR40CW
Samsung Electronics Co., Ltd.
Radiology
105d
Cleared
May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR
Rayence Co., Ltd.
Radiology
123d
Cleared
May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
Rayence Co., Ltd.
Radiology
123d
Cleared
Apr 25, 2014
PHILIPS ELEVA WORKSPOT
Philips Medical Systems Dmc GmbH
Radiology
29d
Cleared
Apr 16, 2014
PVMED DDR 2430T
Portavision Medical, LLC
Radiology
152d
Cleared
Apr 11, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
Rayence Co., Ltd.
Radiology
29d
Cleared
Apr 03, 2014
VIZION ULTRA
Viztek, LLC
Radiology
168d
Cleared
Mar 21, 2014
NOVA FA DR SYSTEM
Sedecal., Sa.
Radiology
99d
Cleared
Mar 11, 2014
BONE SUPPRESSION SOFTWARE
Carestream Health, Inc.
Radiology
119d
Cleared
Feb 21, 2014
FLAATZ 600 SERIES (FLAATZ 600/601)
Drtech Corp.
Radiology
164d