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
Feb 21, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
Rayence Co., Ltd.
Radiology
106d
Cleared
Jan 17, 2014
GALAXY PLUS
Medien International Co, Ltd.
Radiology
122d
Cleared
Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
3Disc Americas
Radiology
107d
Cleared
Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
3Disc Americas
Radiology
107d
Cleared
Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
Fujifilm Medical Systems U.S.A, Inc.
Radiology
105d
Cleared
Nov 05, 2013
DICOMPACS DX-R WITH FLAT PANEL
Oehm Und Rehbein GmbH
Radiology
190d
Cleared
Oct 07, 2013
PHILIPS PIXIUM 4343RC
Philips Medical Systems Dmc GmbH
Radiology
137d
Cleared
Sep 17, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR
Rayence Co., Ltd.
Radiology
148d
Cleared
Aug 29, 2013
CR 12-X DIGITIZER
Agfa Healthcare N.V.
Radiology
106d
Cleared
Aug 22, 2013
AERODR SYSTEM WITH P-31
Konica Minolta Medical & Graphic, Inc.
Radiology
140d
Cleared
Jul 03, 2013
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
Canon, Inc.
Radiology
75d
Cleared
Jul 02, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
Rayence Co., Ltd.
Radiology
89d
Cleared
Jun 25, 2013
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
Swissray Medical AG
Radiology
49d
Cleared
Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
Carestream Health, Inc.
Radiology
99d
Cleared
Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
Carestream Health, Inc.
Radiology
105d
Cleared
May 17, 2013
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
Medicatech USA
Radiology
92d
Cleared
Apr 18, 2013
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
Sedecal., Sa.
Radiology
20d
Cleared
Mar 12, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
Rayence Co., Ltd.
Radiology
132d
Cleared
Mar 11, 2013
DX-D IMAGING PACKAGE
Agfa Healthcare N.V.
Radiology
173d
Cleared
Feb 22, 2013
EOS
Eos Imaging
Radiology
79d
Cleared
Feb 01, 2013
VIVIX-S WIRELESS
Vieworks Co., Ltd.
Radiology
136d
Cleared
Jan 30, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
Rayence Co., Ltd.
Radiology
128d
Cleared
Jan 11, 2013
VIVIX-S WITH VXVUE
Vieworks Co., Ltd.
Radiology
115d
Cleared
Jan 11, 2013
VIZION + DR
Viztek, LLC
Radiology
46d