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
361–384 of 424
Cleared Oct 11, 2002
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K023061
Konica Minolta Medical & Graphic, Inc.
Radiology · 25d
Cleared Oct 04, 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124
Canon, Inc.
Radiology · 15d
Cleared Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829
Eastman Kodak Company
Radiology · 28d
Cleared Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
K020635
Eastman Kodak Company
Radiology · 22d
Cleared Mar 01, 2002
KONICA DIRECT DIGITIZER REGIUS MODEL 350
K013054
Konica Minolta Medical & Graphic, Inc.
Radiology · 171d
Cleared Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218
Fujifilm Medical System U.S.A., Inc.
Radiology · 85d
Cleared Nov 14, 2001
ADC PEDIATRIC
K012750
Agfa Corp.
Radiology · 90d
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