MUH
- Product code
- MUH
- Device name
- System, X-Ray, Extraoral Source, Digital
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.1800
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 15
- Summaries archived here
- 14 (direct download)
- 510(k) clearances (all years, FDA)
- 206 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (15)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251793 | 2026-03-03 | Sota Cloud Corp. | SOTA Cloud Smart Sensor (1.5) | |
| K252570 | 2025-11-10 | Qpix Solutions, Inc. | EzSensor HD, EzSensor UHD | |
| K250687 | 2025-10-24 | Dexcowin Global, Inc. | Cocoon Solo (DX-7020s) | |
| K251206 | 2025-09-24 | Dentimax, Inc. | Digital X-Ray DentiMax Pro Imaging System | |
| K240040 | 2024-10-25 | VATECH Co., Ltd. | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S… | |
| K242778 | 2024-10-11 | Qpix Solutions, Inc. | X Sensor (Model: IOS-A15IF, HDI-15DGF) | |
| K241649 | 2024-07-05 | Zinnovi, Inc. | DUO1 and DUO2 | FDA |
| K232325 | 2024-04-18 | Ray Co., Ltd. | RAYSCAN a-Expert | |
| K231660 | 2023-12-20 | Jiangsu Dynamic Medical Technology Co.… | Digital image scanner of dental | |
| K233053 | 2023-11-21 | Dental Imaging Technologies Corporatio… | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraor… | |
| K230998 | 2023-10-20 | Iray Imaging Technology (Haining) Limi… | Digital Wireless Intraoral X-Ray Sensor | |
| K232552 | 2023-10-20 | Tuxedo Imaging, LLC | TuxDeluxe (Size 1 6100B, Size 2 6101B) | |
| K230916 | 2023-10-10 | Picopack, Inc. | WeSensor | |
| K232255 | 2023-09-27 | Qpix Solutions, Inc. | EZSensor XHD | |
| K232158 | 2023-09-13 | Genoray Co., Ltd. | GenX-CR |
Official FDA classification page: MUH
Classification and pathway per current FDA publications. Data from openFDA (CC0).