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
385–408 of 424
Cleared Apr 27, 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
K050987
Canon, Inc.
Radiology · 8d
Cleared Apr 21, 2005
AGFA CR50.0
K050810
Agfa Corp.
Radiology · 21d
Cleared Jan 13, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
K042602
Ge Medical Systems, LLC
Radiology · 111d
Cleared Dec 15, 2004
DIRECT DIGITIZER, REGIUS MODEL 190
K042386
Konica Minolta Medical & Graphic, Inc.
Radiology · 104d
Cleared Oct 22, 2004
DIGITAL DETECTOR, MODEL GR17
K042821
Anrad Corp.
Radiology · 10d
Cleared Oct 05, 2004
SCANX 14
K042397
Air Techniques, Inc.
Radiology · 33d
Cleared Sep 17, 2004
XPLORER 1600
K042041
Imaging Dynamics Company Limited
Radiology · 50d
Cleared Aug 25, 2004
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
K042023
Fujifilm Medical System U.S.A., Inc.
Radiology · 28d
Cleared Jul 22, 2004
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
K041701
Agfa Corp.
Radiology · 30d
Cleared Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Oct 02, 2003
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
K032210
Alara, Inc.
Radiology · 73d
Cleared Jun 20, 2003
SCANX 10
K031198
Air Techniques, Inc.
Radiology · 65d
Cleared Jun 11, 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K031633
Canon USA, Inc.
Radiology · 15d
Cleared May 21, 2003
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
K031447
Canon, Inc.
Radiology · 14d
Cleared Feb 12, 2003
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K024147
Varian Medical Systems, Inc.
Radiology · 58d
Cleared Nov 22, 2002
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K023750
Canon USA, Inc.
Radiology · 14d
Cleared Nov 05, 2002
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K023586
Canon USA, Inc.
Radiology · 11d
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 May 21, 2002
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
K013897
Bio-Scan S.A
Radiology · 179d
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