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
Jun 24, 2008
DIGITAL RADIOGRAPHY CXDI-60G
Canon, Inc.
Radiology
12d
Cleared
Jun 23, 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
Toshiba America Medical Systems, In.C
Radiology
13d
Cleared
Nov 16, 2007
DRAD-3000E, RADREX-I
Toshiba America Medical Systems, In.C
Radiology
7d
Cleared
Aug 17, 2006
CXDI-40EC
Canon, Inc.
Radiology
15d
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
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
Apr 27, 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
Canon, Inc.
Radiology
8d
Cleared
Jan 13, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
Ge Medical Systems, LLC
Radiology
111d
Cleared
Aug 25, 2004
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
Fujifilm Medical System U.S.A., Inc.
Radiology
28d
Cleared
Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
Fujifilm Medical System U.S.A., Inc.
Radiology
14d
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 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
Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
Eastman Kodak Company
Radiology
22d
Cleared
Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
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
Fujifilm Medical System U.S.A., Inc.
Radiology
87d
Cleared
Oct 13, 1999
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
Canon USA, Inc.
Radiology
75d