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
Cleared
Nov 03, 2005
REGIUS MODEL 170 DIRECT DIGITIZER
Konica Minolta Medical & Graphic, Inc.
Radiology
101d
Cleared
Nov 03, 2005
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
Konica Minolta Medical & Graphic, Inc.
Radiology
101d
Cleared
Sep 21, 2005
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
Cr Tech, Ltd.
Radiology
107d
Cleared
Jul 01, 2005
INSTANT-X, MODELS 1713 & 128
Ann Arbor Digital Devices
Radiology
267d
Cleared
Jul 01, 2005
DIRECT DIGITIZER REGIUS MODEL 370
Konica Minolta Medical & Graphic, Inc.
Radiology
30d
Cleared
Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
Eastman Kodak Company
Radiology
15d
Cleared
Jun 01, 2005
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
Shimadzu Corp.
Radiology
49d
Cleared
May 26, 2005
DDRCOMBI TRAUMA
Swissray International, Inc.
Radiology
66d
Cleared
Apr 27, 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
Canon, Inc.
Radiology
8d
Cleared
Apr 21, 2005
AGFA CR50.0
Agfa Corp.
Radiology
21d
Cleared
Jan 13, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
Ge Medical Systems, LLC
Radiology
111d
Cleared
Dec 15, 2004
DIRECT DIGITIZER, REGIUS MODEL 190
Konica Minolta Medical & Graphic, Inc.
Radiology
104d
Cleared
Oct 22, 2004
DIGITAL DETECTOR, MODEL GR17
Anrad Corp.
Radiology
10d
Cleared
Oct 05, 2004
SCANX 14
Air Techniques, Inc.
Radiology
33d
Cleared
Sep 17, 2004
XPLORER 1600
Imaging Dynamics Company Limited
Radiology
50d
Cleared
Aug 25, 2004
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
Fujifilm Medical System U.S.A., Inc.
Radiology
28d
Cleared
Jul 22, 2004
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
Agfa Corp.
Radiology
30d
Cleared
Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
Fujifilm Medical System U.S.A., Inc.
Radiology
14d
Cleared
Jun 20, 2003
SCANX 10
Air Techniques, Inc.
Radiology
65d
Cleared
Jun 11, 2003
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
Canon USA, Inc.
Radiology
15d
Cleared
May 21, 2003
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
Canon, Inc.
Radiology
14d
Cleared
Feb 12, 2003
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
Varian Medical Systems, Inc.
Radiology
58d
Cleared
Nov 22, 2002
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
Canon USA, Inc.
Radiology
14d
Cleared
Nov 05, 2002
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
Canon USA, Inc.
Radiology
11d