MQB · Class II · 21 CFR 892.1680

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
361–384 of 424
Cleared Nov 02, 2006
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
K063039
Imaging Dynamics Company , Ltd.
Radiology · 30d
Cleared Oct 27, 2006
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
K062376
Rf Systems Lab.
Radiology · 73d
Cleared Oct 13, 2006
CR 85-X
K062742
Agfa Corporation
Radiology · 29d
Cleared Sep 29, 2006
XPLORER 1600 PLUS
K062586
Imaging Dynamics Company , Ltd.
Radiology · 28d
Cleared Sep 18, 2006
CRYSTALVIEW R200
K062390
Alara, Inc.
Radiology · 33d
Cleared Sep 01, 2006
AGFA MODEL CR30-X
K062223
Agfa Corporation
Radiology · 30d
Cleared Aug 17, 2006
CXDI-40EC
K062221
Canon, Inc.
Radiology · 15d
Cleared Jun 30, 2006
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
K061538
Alara, Inc.
Radiology · 28d
Cleared Jun 07, 2006
QUIX DIGITAL RADIOGRAPHIC UPGRADE
K052661
Edge Medical Devices , Ltd.
Radiology · 253d
Cleared May 09, 2006
AXIOM ARISTOS FX PLUS
K061054
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K060137
Eastman Kodak Company
Radiology · 56d
Cleared Mar 10, 2006
DIGITAL RADIOGRAPHY CXDI-50C
K060433
Canon, Inc.
Radiology · 17d
Cleared Jan 17, 2006
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
K053634
Agfa Corporation
Radiology · 19d
Cleared Jan 06, 2006
NDR+/DIVA-D
K053029
Nical Spa
Radiology · 71d
Cleared Nov 17, 2005
CR-PRO
K052938
Eradlink, Inc.
Radiology · 28d
Cleared Nov 03, 2005
REGIUS MODEL 170 DIRECT DIGITIZER
K051998
Konica Minolta Medical & Graphic, Inc.
Radiology · 101d
Cleared Nov 03, 2005
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
K052095
Konica Minolta Medical & Graphic, Inc.
Radiology · 101d
Cleared Sep 21, 2005
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
K051494
Cr Tech, Ltd.
Radiology · 107d
Cleared Aug 25, 2005
GR17 DIGITAL DETECTOR
K052136
Anrad Corp.
Radiology · 20d
Cleared Jul 01, 2005
INSTANT-X, MODELS 1713 & 128
K042791
Ann Arbor Digital Devices
Radiology · 267d
Cleared Jul 01, 2005
DIRECT DIGITIZER REGIUS MODEL 370
K051418
Konica Minolta Medical & Graphic, Inc.
Radiology · 30d
Cleared Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483
Eastman Kodak Company
Radiology · 15d
Cleared Jun 01, 2005
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
K050925
Shimadzu Corp.
Radiology · 49d
Cleared May 26, 2005
DDRCOMBI TRAUMA
K050718
Swissray International, Inc.
Radiology · 66d