MUE · Full Field Digital, System, X-Ray, Mammographic
Radiology · 21 CFR 892.1715 · Class 2
Overview
| Product Code | MUE |
|---|---|
| Device Name | Full Field Digital, System, X-Ray, Mammographic |
| Regulation | 21 CFR 892.1715 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.” See § 892.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”*See* § 892.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 59)
Showing 20 most recent of 59 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | Mar 24, 2026 | SESE |
| K243420 | HESTIA | Genoray Co., Ltd. | Jul 17, 2025 | SESE |
| K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | Mar 12, 2025 | SESE |
| K241113 | VIVIX-M | Vieworks Co., Ltd. | Jan 16, 2025 | SESE |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | Mar 27, 2024 | SESE |
| K220073 | RMF-2000 | DRTECH Corporation | Jan 26, 2023 | SESE |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | Jul 18, 2022 | SESE |
| K212873 | Aspire Cristalle | Fujifilm Corporation | May 27, 2022 | SESE |
| K210151 | Digimamo D | Vmi Tecnologias Ltda | Mar 1, 2022 | SESE |
| K202822 | Helianthus | Metaltronica Spa | Dec 15, 2021 | SESE |
| K211725 | Senographe Pristina | GE Healthcare | Aug 6, 2021 | SESE |
| K211215 | SenoBright HD | GE Healthcare | Jun 22, 2021 | SESE |
| K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | Jun 21, 2021 | SESE |
| K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | Oct 23, 2020 | SESE |
| K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | Ims Giotto S.P.A. | Jun 18, 2020 | SESE |
| K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | Jun 12, 2020 | SESE |
| K193334 | Pristina Serena Bright | GE Healthcare | May 15, 2020 | SESE |
| K190809 | Sample Imaging for Senographe Pristina | GE Healthcare | Jul 29, 2019 | SESE |
| K182951 | Pristina Serena 3D | GE Healthcare | Jan 18, 2019 | SESE |
| K173576 | Pristina Serena | GE Healthcare | May 14, 2018 | SESE |
Top Applicants
- GE Healthcare — 10 clearances
- Siemens Medical Solutions USA, Inc. — 6 clearances
- Planmed OY — 4 clearances
- Philips Digital Mammography Sweden AB — 3 clearances
- Hologic, Inc. — 3 clearances
