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
Declining activity - 14 submissions in the last 2 years vs 28 in the prior period
Review times increasing: avg 133d recently vs 78d historically

FDA 510(k) Cleared Solid State X-ray Imager (flat Panel/digital Imager) Devices (Product Code MQB)

421 devices
1–24 of 421
Cleared Oct 09, 2025
Lux HD 2530 detector (Lux HD 2530)
K252911
Iray Imaging Technology (Haining) Limited
Radiology · 27d
Cleared Jul 22, 2025
Yushan X-Ray Flat Panel Detector
K250211
Innocare Optoelectronics Corp.
Radiology · 179d
Cleared Jun 17, 2025
SKR 3000
K250665
Konica Minolta, Inc.
Radiology · 104d
Cleared Apr 18, 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734
Allengers Medical Systems Limited
Radiology · 135d
Cleared Mar 20, 2025
EXPD 114
K242770
DRTECH Corporation
Radiology · 188d
Cleared Mar 19, 2025
EXPD 4343N1
K243443
DRTECH Corporation
Radiology · 133d
Cleared Mar 18, 2025
Lux HD 35 Detector (Lux HD 35)
K243556
Iray Imaging Technology (Haining) Limited
Radiology · 120d
Cleared Feb 24, 2025
ExamVue Apex
K244010
Jpi Healthcare Co, Ltd.
Radiology · 60d
Cleared Dec 19, 2024
Yushan X-Ray Flat Panel Detector
K243171
Innocare Optoelectronics Corp.
Radiology · 80d
Cleared Nov 21, 2024
SKR 3000
K241319
Konica Minolta, Inc.
Radiology · 195d
Cleared Nov 15, 2024
VIVIX-S 1751S
K241125
Vieworks Co., Ltd.
Radiology · 206d
Cleared Nov 12, 2024
PRORAD X-Ray Flat Panel Detector with DROC
K240771
Prognosys Medical Systems Private Limited
Radiology · 236d
Cleared Nov 07, 2024
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
K241346
Aspen Imaging Healthcare, Inc.
Radiology · 178d
Cleared Sep 09, 2024
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
K242394
Rayence Co., Ltd.
Radiology · 27d
Cleared Mar 07, 2024
0909FCC, 0909FCC-HS
K240371
Rayence Co., Ltd.
Radiology · 29d
Cleared Feb 13, 2024
EXPD 4343S
K232082
DRTECH Corporation
Radiology · 215d
Cleared Nov 16, 2023
EXPD 4343D
K232753
DRTECH Corporation
Radiology · 69d
Cleared Sep 01, 2023
MasterX 800 Series
K230918
Medicatech USA
Radiology · 151d
Cleared Aug 03, 2023
YosemiteView 4343W/YosemiteView 3643W
K232058
Careray Digital Medical Technology Co., Ltd.
Radiology · 23d
Cleared Aug 01, 2023
EXPD 4357
K231959
DRTECH Corporation
Radiology · 29d
Cleared Jul 12, 2023
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
K231709
Radmedix, LLC
Radiology · 30d
Cleared Jun 21, 2023
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
K231467
Rayence Co., Ltd.
Radiology · 30d
Cleared Mar 06, 2023
A1417MCW/A1717MCW/F1417MCW
K223930
H&abyz Co., Ltd.
Radiology · 66d
Cleared Feb 15, 2023
Digital Radiography CXDI-CS01
K230175
Canon, Inc.
Radiology · 26d

About Product Code MQB - Regulatory Context

510(k) Submission Activity

421 total 510(k) submissions under product code MQB since 1997, with 421 receiving FDA clearance (average review time: 80 days).

Submission volume has declined in recent years - 14 submissions in the last 24 months compared to 28 in the prior period.

FDA 510(k) Review Time - MQB Product Code

Recent submissions under MQB have taken an average of 133 days to reach a decision - up from 78 days historically. Manufacturers should account for longer review timelines in current project planning.

MQB devices are reviewed by the Radiology panel. Browse all Radiology devices →