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
241–264 of 424
Cleared Feb 21, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
K133409
Rayence Co., Ltd.
Radiology · 106d
Cleared Jan 17, 2014
GALAXY PLUS
K132921
Medien International Co, Ltd.
Radiology · 122d
Cleared Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
K133106
3Disc Americas
Radiology · 107d
Cleared Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
K133120
3Disc Americas
Radiology · 107d
Cleared Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K132509
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 105d
Cleared Nov 05, 2013
DICOMPACS DX-R WITH FLAT PANEL
K131211
Oehm Und Rehbein GmbH
Radiology · 190d
Cleared Oct 07, 2013
PHILIPS PIXIUM 4343RC
K131483
Philips Medical Systems Dmc GmbH
Radiology · 137d
Cleared Sep 17, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR
K131114
Rayence Co., Ltd.
Radiology · 148d
Cleared Aug 29, 2013
CR 12-X DIGITIZER
K131408
Agfa Healthcare N.V.
Radiology · 106d
Cleared Aug 22, 2013
AERODR SYSTEM WITH P-31
K130936
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,
K131106
Canon, Inc.
Radiology · 75d
Cleared Jul 02, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
K130935
Rayence Co., Ltd.
Radiology · 89d
Cleared Jun 25, 2013
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K131314
Swissray Medical AG
Radiology · 49d
Cleared Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567
Carestream Health, Inc.
Radiology · 99d
Cleared Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464
Carestream Health, Inc.
Radiology · 105d
Cleared May 17, 2013
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K130377
Medicatech USA
Radiology · 92d
Cleared Apr 18, 2013
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
K130883
Sedecal., Sa.
Radiology · 20d
Cleared Mar 12, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
K123345
Rayence Co., Ltd.
Radiology · 132d
Cleared Mar 11, 2013
DX-D IMAGING PACKAGE
K122736
Agfa Healthcare N.V.
Radiology · 173d
Cleared Feb 22, 2013
EOS
K123740
Eos Imaging
Radiology · 79d
Cleared Feb 01, 2013
VIVIX-S WIRELESS
K122865
Vieworks Co., Ltd.
Radiology · 136d
Cleared Jan 30, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
K122928
Rayence Co., Ltd.
Radiology · 128d
Cleared Jan 11, 2013
VIVIX-S WITH VXVUE
K122866
Vieworks Co., Ltd.
Radiology · 115d
Cleared Jan 11, 2013
VIZION + DR
K123644
Viztek, LLC
Radiology · 46d