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
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
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
Cleared
Nov 14, 2001
ADC PEDIATRIC
Agfa Corp.
Radiology
90d
Cleared
Jun 02, 2000
XPLORER 1000
Imaging Dynamics Corp.
Radiology
275d
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
Nov 09, 1999
STINGRAY DR, MODEL 1
Infimed, Inc.
Radiology
82d
Cleared
Oct 13, 1999
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
Canon USA, Inc.
Radiology
75d
Cleared
Aug 17, 1999
KONICA DIRECT DIGITIZER, MODEL DD-341
Konica Corp.
Radiology
193d
Cleared
Apr 21, 1999
THORAX FD AND MULTIX FD
Siemens Medical Solutions USA, Inc.
Radiology
181d
Cleared
Dec 11, 1998
CDR - PAN MODEL 4700
Schick Technologies, Inc.
Radiology
134d
Cleared
Nov 24, 1998
PHILIPS BUCKY VISION
Philips Medical Systems, Inc.
Radiology
106d
Cleared
Nov 04, 1998
CANON X-RAY DIGITAL CAMERA CXDI-11
Canon USA, Inc.
Radiology
187d
Cleared
Dec 04, 1997
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
Sterling Diagnostic Imaging, Inc.
Radiology
100d