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
409–424 of 424
Cleared Nov 14, 2001
ADC PEDIATRIC
K012750
Agfa Corp.
Radiology · 90d
Cleared Oct 01, 2001
SOLID STATE X-RAY IMAGING DEVICES
K003238
Cares Built, Inc.
Radiology · 349d
Cleared Sep 28, 2001
ADC COMPACT PLUS
K013138
Agfa-Gevaert AG
Radiology · 9d
Cleared Jul 03, 2001
SMART RAD
K003438
Cmt Medical Technologies, Ltd.
Radiology · 239d
Cleared Dec 27, 2000
PHORMAX EAGLE SCANNER SYSTEM
K001499
Phormax Corp.
Radiology · 226d
Cleared Nov 08, 2000
PCCR DIGITAL IMAGING DEVICE
K003256
Orex Computed Radiography, Ltd.
Radiology · 22d
Cleared Jun 02, 2000
XPLORER 1000
K992955
Imaging Dynamics Corp.
Radiology · 275d
Cleared Feb 10, 2000
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
K993861
Fujifilm Medical System U.S.A., Inc.
Radiology · 87d
Cleared Nov 09, 1999
STINGRAY DR, MODEL 1
K992794
Infimed, Inc.
Radiology · 82d
Cleared Oct 13, 1999
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
K992547
Canon USA, Inc.
Radiology · 75d
Cleared Aug 17, 1999
KONICA DIRECT DIGITIZER, MODEL DD-341
K990359
Konica Corp.
Radiology · 193d
Cleared Apr 21, 1999
THORAX FD AND MULTIX FD
K983732
Siemens Medical Solutions USA, Inc.
Radiology · 181d
Cleared Dec 11, 1998
CDR - PAN MODEL 4700
K982661
Schick Technologies, Inc.
Radiology · 134d
Cleared Nov 24, 1998
PHILIPS BUCKY VISION
K982795
Philips Medical Systems, Inc.
Radiology · 106d
Cleared Nov 04, 1998
CANON X-RAY DIGITAL CAMERA CXDI-11
K981556
Canon USA, Inc.
Radiology · 187d
Cleared Dec 04, 1997
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
K973206
Sterling Diagnostic Imaging, Inc.
Radiology · 100d