MUH — System, X-Ray, Extraoral Source, Digital Class II
FDA product code MUH covers "System, X-Ray, Extraoral Source, Digital", a Class II medical device regulated under 21 CFR 872.1800. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MUH
- Device Class
- Class II
- Regulation Number
- 872.1800
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251793 | sota cloud | SOTA Cloud Smart Sensor (1.5) | March 3, 2026 |
| K252570 | qpix solutions | EzSensor HD, EzSensor UHD | November 10, 2025 |
| K250687 | dexcowin global | Cocoon Solo (DX-7020s) | October 24, 2025 |
| K251206 | dentimax | Digital X-Ray DentiMax Pro Imaging System | September 24, 2025 |
| K240040 | vatech co | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta | October 25, 2024 |
| K242778 | qpix solutions | X Sensor (Model: IOS-A15IF, HDI-15DGF) | October 11, 2024 |
| K241649 | zinnovi | DUO1 and DUO2 | July 5, 2024 |
| K232325 | ray co | RAYSCAN a-Expert | April 18, 2024 |
| K231660 | jiangsu dynamic medical technology co | Digital image scanner of dental | December 20, 2023 |
| K233053 | dental imaging technologies corporation | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 | November 21, 2023 |
| K230998 | iray imaging technology (haining) limited | Digital Wireless Intraoral X-Ray Sensor | October 20, 2023 |
| K232552 | tuxedo imaging | TuxDeluxe (Size 1 6100B, Size 2 6101B) | October 20, 2023 |
| K230916 | picopack | WeSensor | October 10, 2023 |
| K232255 | qpix solutions | EZSensor XHD | September 27, 2023 |
| K232158 | genoray co | GenX-CR | September 13, 2023 |
| K231202 | denterprise international | QuickRayPRO | June 22, 2023 |
| K230811 | iray imaging technology (haining) limited | Digital Intraoral X-Ray Sensor | April 21, 2023 |
| K230732 | alliage s/a industrias medica odontológico | Eagle S/Saevo Slim/D700 Slim | April 11, 2023 |
| K230095 | durr dental se | ScanX Swift 2.0, ScanX Swift View 2.0 | February 6, 2023 |
| K221955 | realcloud imaging inc. dba realcloud imaging | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | August 31, 2022 |