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 Iray Technology Taicang , Ltd., Canon, Inc. and DRTECH Corporation.
421
Total
421
Cleared
80d
Avg days
1997
Since
421 devices
Cleared
Mar 24, 2021
I-Q View
First Source, Inc.
Radiology
96d
Cleared
Mar 12, 2021
ADD
H&abyz Co., Ltd.
Radiology
136d
Cleared
Mar 03, 2021
Mars 1417X Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
28d
Cleared
Mar 02, 2021
Mars1717X Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
27d
Cleared
Feb 19, 2021
X-ray Flat Panel Detectors/CareView 3600RF
Careray Digital Medical System Co., Ltd.
Radiology
141d
Cleared
Jan 26, 2021
General Radiography CXDI-CS01
Canon, Inc.
Radiology
26d
Cleared
Dec 02, 2020
Lux 35 Detector
Carestream Health
Radiology
40d
Cleared
Oct 26, 2020
1212FCA
Rayence Co., Ltd.
Radiology
39d
Cleared
Oct 11, 2020
Yushan X-Ray Flat Panel Detector with DROC
Innocare Optoelectronics Corp.
Radiology
125d
Cleared
Sep 30, 2020
DigitalDiagnost C90
Philips Medical Systems Dmc GmbH
Radiology
26d
Cleared
Sep 03, 2020
Flat Panel Detector
Ka Imaging, Inc.
Radiology
83d
Cleared
Aug 07, 2020
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
Careray Digital Medical System Co., Ltd.
Radiology
25d
Cleared
Jul 23, 2020
1717SCV, 1717SGV
Rayence Co., Ltd.
Radiology
23d
Cleared
Jun 29, 2020
Edge Air(1417) Digital Flat Panel X-ray Detector
Osko, Inc.
Radiology
24d
Cleared
Jun 10, 2020
Intraoral Sensor
Dentium Co., Ltd (Ict Branch)
Radiology
30d
Cleared
May 12, 2020
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
Iray Technology Taicang , Ltd.
Radiology
22d
Cleared
May 06, 2020
Accuvue+
Radmedix, LLC
Radiology
15d
Cleared
May 01, 2020
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
Iray Technology Taicang , Ltd.
Radiology
15d
Cleared
Apr 23, 2020
BSD3543W
Bontech Co., Ltd.
Radiology
28d
Cleared
Apr 10, 2020
DR-ID 1200SDK System
Fujifilm Corporation
Radiology
28d
Cleared
Apr 01, 2020
Focus 43C detector, TRIMAX 43C detector
Iray Technology Taicang , Ltd.
Radiology
23d
Cleared
Mar 18, 2020
VIVIX-S VW
Vieworks Co., Ltd.
Radiology
27d
Cleared
Feb 18, 2020
Vita Flex CR System with LLI
Carestream Health, Inc.
Radiology
130d
Cleared
Feb 14, 2020
E-COM DR-2000 DR
Livermoretech, Inc.
Radiology
46d