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 02, 2006
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
Imaging Dynamics Company , Ltd.
Radiology
30d
Cleared
Oct 27, 2006
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
Rf Systems Lab.
Radiology
73d
Cleared
Oct 13, 2006
CR 85-X
Agfa Corporation
Radiology
29d
Cleared
Sep 29, 2006
XPLORER 1600 PLUS
Imaging Dynamics Company , Ltd.
Radiology
28d
Cleared
Sep 18, 2006
CRYSTALVIEW R200
Alara, Inc.
Radiology
33d
Cleared
Sep 01, 2006
AGFA MODEL CR30-X
Agfa Corporation
Radiology
30d
Cleared
Aug 17, 2006
CXDI-40EC
Canon, Inc.
Radiology
15d
Cleared
Jun 30, 2006
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
Alara, Inc.
Radiology
28d
Cleared
Jun 07, 2006
QUIX DIGITAL RADIOGRAPHIC UPGRADE
Edge Medical Devices , Ltd.
Radiology
253d
Cleared
May 09, 2006
AXIOM ARISTOS FX PLUS
Siemens Medical Solutions USA, Inc.
Radiology
22d
Cleared
Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
Eastman Kodak Company
Radiology
56d
Cleared
Mar 10, 2006
DIGITAL RADIOGRAPHY CXDI-50C
Canon, Inc.
Radiology
17d
Cleared
Jan 17, 2006
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
Agfa Corporation
Radiology
19d
Cleared
Jan 06, 2006
NDR+/DIVA-D
Nical Spa
Radiology
71d
Cleared
Nov 17, 2005
CR-PRO
Eradlink, Inc.
Radiology
28d
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
Aug 25, 2005
GR17 DIGITAL DETECTOR
Anrad Corp.
Radiology
20d
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