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
193–216 of 424
Cleared Jun 24, 2008
DIGITAL RADIOGRAPHY CXDI-60G
K081648
Canon, Inc.
Radiology · 12d
Cleared Jun 23, 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Nov 16, 2007
DRAD-3000E, RADREX-I
K073165
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Aug 17, 2006
CXDI-40EC
K062221
Canon, Inc.
Radiology · 15d
Cleared May 09, 2006
AXIOM ARISTOS FX PLUS
K061054
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K060137
Eastman Kodak Company
Radiology · 56d
Cleared Mar 10, 2006
DIGITAL RADIOGRAPHY CXDI-50C
K060433
Canon, Inc.
Radiology · 17d
Cleared Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483
Eastman Kodak Company
Radiology · 15d
Cleared Jun 01, 2005
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
K050925
Shimadzu Corp.
Radiology · 49d
Cleared Apr 27, 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
K050987
Canon, Inc.
Radiology · 8d
Cleared Jan 13, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
K042602
Ge Medical Systems, LLC
Radiology · 111d
Cleared Aug 25, 2004
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
K042023
Fujifilm Medical System U.S.A., Inc.
Radiology · 28d
Cleared Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
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 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 Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218
Fujifilm Medical System U.S.A., Inc.
Radiology · 85d
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 Oct 13, 1999
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
K992547
Canon USA, Inc.
Radiology · 75d