MUE — Full Field Digital, System, X-Ray, Mammographic Class II
FDA product code MUE covers "Full Field Digital, System, X-Ray, Mammographic", a Class II medical device regulated under 21 CFR 892.1715. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MUE
- Device Class
- Class II
- Regulation Number
- 892.1715
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253678 | siemens medical solutions usa | MAMMOMAT B.brilliant (11372950) | June 18, 2026 |
| K254092 | vieworks co | Bellalun 2D (VDMS-1000S) | May 28, 2026 |
| K260087 | ge medical systems scs | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | March 24, 2026 |
| K243420 | genoray co | HESTIA | July 17, 2025 |
| K243849 | rayence co | 2430TCA with Xmaru W | March 12, 2025 |
| K241113 | vieworks co | VIVIX-M | January 16, 2025 |
| K233539 | siemens medical solutions usa | MAMMOMAT B.brilliant | March 27, 2024 |
| K220073 | drtech corporation | RMF-2000 | January 26, 2023 |
| K211720 | planmed | Planmed Clarity 2D, Planmed Clarify S | July 18, 2022 |
| K212873 | fujifilm corporation | Aspire Cristalle | May 27, 2022 |
| K210151 | vmi tecnologias ltda | Digimamo D | March 1, 2022 |
| K202822 | metaltronica | Helianthus | December 15, 2021 |
| K211725 | ge healthcare | Senographe Pristina | August 6, 2021 |
| K211215 | ge healthcare | SenoBright HD | June 22, 2021 |
| K202902 | rayence co | 2430MCA with Xmaru W | June 21, 2021 |
| K192317 | planmed | Planmed Clarity 2D and Clarity S | October 23, 2020 |
| K200424 | ims giotto | Giotto Class (Models - 3000X-YY and 4000X-YY) | June 18, 2020 |
| K193166 | siemens medical solutions usa | MAMMOMAT Revelation | June 12, 2020 |
| K193334 | ge healthcare | Pristina Serena Bright | May 15, 2020 |
| K190809 | ge healthcare | Sample Imaging for Senographe Pristina | July 29, 2019 |