MUH · System, X-Ray, Extraoral Source, Digital
Dental · 21 CFR 872.1800 · Class 2
Overview
| Product Code | MUH |
|---|---|
| Device Name | System, X-Ray, Extraoral Source, Digital |
| Regulation | 21 CFR 872.1800 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 206)
Showing 20 most recent of 206 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | Mar 3, 2026 | SESE |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | Nov 10, 2025 | SESE |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | Oct 24, 2025 | SESE |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | Sep 24, 2025 | SESE |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | VATECH Co., Ltd. | Oct 25, 2024 | SESE |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | Oct 11, 2024 | SESE |
| K241649 | DUO1 and DUO2 | Zinnovi, Inc. | Jul 5, 2024 | SESE |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | Apr 18, 2024 | SESE |
| K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | Dec 20, 2023 | SESE |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation | Nov 21, 2023 | SESE |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | Oct 20, 2023 | SESE |
| K230998 | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | Oct 20, 2023 | SESE |
| K230916 | WeSensor | Picopack, Inc. | Oct 10, 2023 | SESE |
| K232255 | EZSensor XHD | Qpix Solutions, Inc. | Sep 27, 2023 | SESE |
| K232158 | GenX-CR | Genoray Co., Ltd. | Sep 13, 2023 | SESE |
| K231202 | QuickRayPRO | Denterprise International, Inc. | Jun 22, 2023 | SESE |
| K230811 | Digital Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | Apr 21, 2023 | SESE |
| K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | Apr 11, 2023 | SESE |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | Feb 6, 2023 | SESE |
| K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | Aug 31, 2022 | SESE |
Top Applicants
- VATECH Co., Ltd. — 8 clearances
- Sirona Dental Systems GmbH — 7 clearances
- Genoray Co., Ltd. — 7 clearances
- Trophy — 6 clearances
- Soredex Palodex Group OY — 5 clearances
