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
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
Oct 02, 2003
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
Alara, Inc.
Radiology
73d
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
Cleared
Oct 11, 2002
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
Konica Minolta Medical & Graphic, Inc.
Radiology
25d
Cleared
Oct 04, 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
Canon, Inc.
Radiology
15d
Cleared
Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
Eastman Kodak Company
Radiology
28d
Cleared
May 21, 2002
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
Bio-Scan S.A
Radiology
179d
Cleared
Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
Eastman Kodak Company
Radiology
22d
Cleared
Mar 01, 2002
KONICA DIRECT DIGITIZER REGIUS MODEL 350
Konica Minolta Medical & Graphic, Inc.
Radiology
171d
Cleared
Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
Fujifilm Medical System U.S.A., Inc.
Radiology
85d