MUE — Full Field Digital, System, X-Ray, Mammographic Class II
FDA Device Classification
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 |
|---|
| 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 |
| K182951 | ge healthcare | Pristina Serena 3D | January 18, 2019 |
| K173576 | ge healthcare | Pristina Serena | May 14, 2018 |
| K173408 | siemens medi cal solutions | Mammomat Revelation | March 21, 2018 |