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 12, 2017
Aquarius 8600 1417TG and Aquarius 8600 1717TG
Imaging Dynamics Company , Ltd.
Radiology
174d
Cleared
Oct 12, 2017
SKR 3000
Konica Minolta, Inc.
Radiology
27d
Cleared
Oct 06, 2017
Edge Air Digital Flat Panel X-ray Detector
Osko, Inc.
Radiology
30d
Cleared
Oct 06, 2017
Edge Digital Flat Panel X-ray Detector
Osko, Inc.
Radiology
30d
Cleared
Oct 05, 2017
Aquarius 8600 1417WC
Imaging Dynamics Company , Ltd.
Radiology
167d
Cleared
Sep 26, 2017
CareView 1800Cw X-ray Flat Panel Detectors
Careray Digital Medical System Co., Ltd.
Radiology
29d
Cleared
Aug 25, 2017
SKR 3000
Konica Minolta, Inc.
Radiology
77d
Cleared
Jul 07, 2017
Models 3543A, 4343A, 2929A and A843B
Shanghai PZ Medical Technolgoy Co., Ltd.
Radiology
141d
Cleared
Jul 07, 2017
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
Philips Medical Systems Dmc GmbH
Radiology
50d
Cleared
Jun 30, 2017
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
Fujifilm Medical Systems U.S.A, Inc.
Radiology
190d
Cleared
Jun 21, 2017
BSD4343R Digital Flat Panel X-ray Detector
Bontech, Inc.
Radiology
30d
Cleared
Jun 12, 2017
1417WGC_127um and 1417WGC_140um
Rayence Co., Ltd.
Radiology
28d
Cleared
Jun 12, 2017
1417WCC_127um and1417WCC_140um
Rayence Co., Ltd.
Radiology
28d
Cleared
Jun 09, 2017
1717SGC_127um and 1717SGC_140um
Rayence Co., Ltd.
Radiology
25d
Cleared
Jun 09, 2017
1717SCC_127um and 1717SCC_140um
Rayence Co., Ltd.
Radiology
25d
Cleared
May 17, 2017
Nexus DR Digital X-ray Imaging System
Varex Imaging Corporation
Radiology
29d
Cleared
May 15, 2017
EVS 2430W, EVS 2430GW
DRTECH Corporation
Radiology
28d
Cleared
May 11, 2017
GMR40
Neurologica Corporation, A Subsidiary OF
Radiology
29d
Cleared
May 01, 2017
Televere Digital Imaging System
Televere Systems
Radiology
28d
Cleared
Mar 21, 2017
SmartGrid
Carestream Health
Radiology
131d
Cleared
Mar 01, 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
Canon, Inc.
Radiology
27d
Cleared
Feb 22, 2017
Aquarius 8600
Imaging Dynamics Company , Ltd.
Radiology
30d
Cleared
Feb 09, 2017
pixium 4343RCE
Philips Medical Systems Dmc GmbH
Radiology
28d
Cleared
Feb 08, 2017
VIVIX-S 1417N
Vieworks Co., Ltd.
Radiology
41d