MUH · Class II · 21 CFR 872.1800

FDA Product Code MUH: System, X-ray, Extraoral Source, Digital

FDA product code MUH covers digital extraoral dental X-ray systems used for panoramic and cephalometric imaging.

These systems use a rotating X-ray source and digital sensor to capture wide-field images of the entire dentition, jaws, and surrounding structures in a single exposure. They are the standard imaging modality for orthodontic assessment, implant planning, and evaluation of jaw pathology.

MUH devices are Class II medical devices, regulated under 21 CFR 872.1800 and reviewed by the FDA Radiology panel.

Leading manufacturers include Qpix Solutions, Inc., Iray Technology Taicang , Ltd. and Iray Imaging Technology (Haining) Limited.

206
Total
206
Cleared
101d
Avg days
1998
Since
Declining activity - 7 submissions in the last 2 years vs 13 in the prior period
Review times increasing: avg 156d recently vs 99d historically

FDA 510(k) Cleared System, X-ray, Extraoral Source, Digital Devices (Product Code MUH)

206 devices
1–24 of 206
Cleared Mar 03, 2026
SOTA Cloud Smart Sensor (1.5)
K251793
Sota Cloud Corp.
Radiology · 265d
Cleared Nov 10, 2025
EzSensor HD, EzSensor UHD
K252570
Qpix Solutions, Inc.
Radiology · 88d
Cleared Oct 24, 2025
Cocoon Solo (DX-7020s)
K250687
Dexcowin Global, Inc.
Radiology · 232d
Cleared Sep 24, 2025
Digital X-Ray DentiMax Pro Imaging System
K251206
Dentimax, Inc.
Radiology · 159d
Cleared Oct 25, 2024
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040
VATECH Co., Ltd.
Radiology · 294d
Cleared Oct 11, 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778
Qpix Solutions, Inc.
Radiology · 28d
Cleared Jul 05, 2024
DUO1 and DUO2
K241649
Zinnovi, Inc.
Radiology · 28d
Cleared Apr 18, 2024
RAYSCAN a-Expert
K232325
Ray Co., Ltd.
Radiology · 259d
Cleared Dec 20, 2023
Digital image scanner of dental
K231660
Jiangsu Dynamic Medical Technology Co., Ltd.
Radiology · 196d
Cleared Nov 21, 2023
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
K233053
Dental Imaging Technologies Corporation
Radiology · 57d
Cleared Oct 20, 2023
Digital Wireless Intraoral X-Ray Sensor
K230998
Iray Imaging Technology (Haining) Limited
Radiology · 196d
Cleared Oct 20, 2023
TuxDeluxe (Size 1 6100B, Size 2 6101B)
K232552
Tuxedo Imaging, LLC
Radiology · 58d
Cleared Oct 10, 2023
WeSensor
K230916
Picopack, Inc.
Radiology · 190d
Cleared Sep 27, 2023
EZSensor XHD
K232255
Qpix Solutions, Inc.
Radiology · 61d
Cleared Sep 13, 2023
GenX-CR
K232158
Genoray Co., Ltd.
Radiology · 55d
Cleared Jun 22, 2023
QuickRayPRO
K231202
Denterprise International, Inc.
Radiology · 56d
Cleared Apr 21, 2023
Digital Intraoral X-Ray Sensor
K230811
Iray Imaging Technology (Haining) Limited
Radiology · 28d
Cleared Apr 11, 2023
Eagle S/Saevo Slim/D700 Slim
K230732
Alliage S/A Industrias Medica Odontol?gico.
Radiology · 26d
Cleared Feb 06, 2023
ScanX Swift 2.0, ScanX Swift View 2.0
K230095
Durr Dental SE
Radiology · 25d
Cleared Aug 31, 2022
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
K221955
Realcloud Imaging Inc. Dba Realcloud Imaging
Radiology · 57d
Cleared Jun 22, 2022
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
K221008
Shanghai Handy Medical Equipment Co., Ltd.
Radiology · 78d
Cleared May 19, 2022
PAPAYA & PAPAYA Plus
K220423
Genoray Co., Ltd.
Radiology · 94d
Cleared Apr 13, 2022
OpenSensorX Series
K220556
Dentimax, Inc.
Radiology · 44d
Cleared Mar 11, 2022
Dental sensors NanoPix1, NanoPix2
K220422
Iray Technology Taicang , Ltd.
Radiology · 25d

About Product Code MUH - Regulatory Context

510(k) Submission Activity

206 total 510(k) submissions under product code MUH since 1998, with 206 receiving FDA clearance (average review time: 101 days).

Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 13 in the prior period.

FDA 510(k) Review Time - MUH Product Code

Recent submissions under MUH have taken an average of 156 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.

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