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 Iray Technology Taicang , Ltd., Canon, Inc. and DRTECH Corporation.

421
Total
421
Cleared
80d
Avg days
1997
Since
421 devices
73–96 of 421
Cleared Mar 24, 2021
I-Q View
K203703
First Source, Inc.
Radiology · 96d
Cleared Mar 12, 2021
ADD
K203188
H&abyz Co., Ltd.
Radiology · 136d
Cleared Mar 03, 2021
Mars 1417X Wireless Digital Flat Panel Detector
K210316
Iray Technology Taicang , Ltd.
Radiology · 28d
Cleared Mar 02, 2021
Mars1717X Wireless Digital Flat Panel Detector
K210314
Iray Technology Taicang , Ltd.
Radiology · 27d
Cleared Feb 19, 2021
X-ray Flat Panel Detectors/CareView 3600RF
K202995
Careray Digital Medical System Co., Ltd.
Radiology · 141d
Cleared Jan 26, 2021
General Radiography CXDI-CS01
K203849
Canon, Inc.
Radiology · 26d
Cleared Dec 02, 2020
Lux 35 Detector
K203159
Carestream Health
Radiology · 40d
Cleared Oct 26, 2020
1212FCA
K202722
Rayence Co., Ltd.
Radiology · 39d
Cleared Oct 11, 2020
Yushan X-Ray Flat Panel Detector with DROC
K201528
Innocare Optoelectronics Corp.
Radiology · 125d
Cleared Sep 30, 2020
DigitalDiagnost C90
K202564
Philips Medical Systems Dmc GmbH
Radiology · 26d
Cleared Sep 03, 2020
Flat Panel Detector
K201591
Ka Imaging, Inc.
Radiology · 83d
Cleared Aug 07, 2020
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
K201932
Careray Digital Medical System Co., Ltd.
Radiology · 25d
Cleared Jul 23, 2020
1717SCV, 1717SGV
K201796
Rayence Co., Ltd.
Radiology · 23d
Cleared Jun 29, 2020
Edge Air(1417) Digital Flat Panel X-ray Detector
K201503
Osko, Inc.
Radiology · 24d
Cleared Jun 10, 2020
Intraoral Sensor
K201247
Dentium Co., Ltd (Ict Branch)
Radiology · 30d
Cleared May 12, 2020
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
K201043
Iray Technology Taicang , Ltd.
Radiology · 22d
Cleared May 06, 2020
Accuvue+
K201058
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
K201004
Iray Technology Taicang , Ltd.
Radiology · 15d
Cleared Apr 23, 2020
BSD3543W
K200787
Bontech Co., Ltd.
Radiology · 28d
Cleared Apr 10, 2020
DR-ID 1200SDK System
K200668
Fujifilm Corporation
Radiology · 28d
Cleared Apr 01, 2020
Focus 43C detector, TRIMAX 43C detector
K200622
Iray Technology Taicang , Ltd.
Radiology · 23d
Cleared Mar 18, 2020
VIVIX-S VW
K200418
Vieworks Co., Ltd.
Radiology · 27d
Cleared Feb 18, 2020
Vita Flex CR System with LLI
K192894
Carestream Health, Inc.
Radiology · 130d
Cleared Feb 14, 2020
E-COM DR-2000 DR
K193644
Livermoretech, Inc.
Radiology · 46d