Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1715](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1715) → MUE — Full Field Digital, System, X-Ray, Mammographic # MUE · Full Field Digital, System, X-Ray, Mammographic _Radiology · 21 CFR 892.1715 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE ## Overview - **Product Code:** MUE - **Device Name:** Full Field Digital, System, X-Ray, Mammographic - **Regulation:** [21 CFR 892.1715](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1715) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K260087.md) | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | Mar 24, 2026 | SESE | | [K243420](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K243420.md) | HESTIA | Genoray Co., Ltd. | Jul 17, 2025 | SESE | | [K243849](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K243849.md) | 2430TCA with Xmaru W | Rayence Co., Ltd. | Mar 12, 2025 | SESE | | [K241113](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K241113.md) | VIVIX-M | Vieworks Co., Ltd. | Jan 16, 2025 | SESE | | [K233539](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K233539.md) | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | Mar 27, 2024 | SESE | | [K220073](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K220073.md) | RMF-2000 | DRTECH Corporation | Jan 26, 2023 | SESE | | [K211720](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K211720.md) | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | Jul 18, 2022 | SESE | | [K212873](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K212873.md) | Aspire Cristalle | Fujifilm Corporation | May 27, 2022 | SESE | | [K210151](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K210151.md) | Digimamo D | Vmi Tecnologias Ltda | Mar 1, 2022 | SESE | | [K202822](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K202822.md) | Helianthus | Metaltronica Spa | Dec 15, 2021 | SESE | | [K211725](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K211725.md) | Senographe Pristina | GE Healthcare | Aug 6, 2021 | SESE | | [K211215](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K211215.md) | SenoBright HD | GE Healthcare | Jun 22, 2021 | SESE | | [K202902](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K202902.md) | 2430MCA with Xmaru W | Rayence Co., Ltd. | Jun 21, 2021 | SESE | | [K192317](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K192317.md) | Planmed Clarity 2D and Clarity S | Planmed OY | Oct 23, 2020 | SESE | | [K200424](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K200424.md) | Giotto Class (Models - 3000X-YY and 4000X-YY) | Ims Giotto S.P.A. | Jun 18, 2020 | SESE | | [K193166](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K193166.md) | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | Jun 12, 2020 | SESE | | [K193334](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K193334.md) | Pristina Serena Bright | GE Healthcare | May 15, 2020 | SESE | | [K190809](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K190809.md) | Sample Imaging for Senographe Pristina | GE Healthcare | Jul 29, 2019 | SESE | | [K182951](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K182951.md) | Pristina Serena 3D | GE Healthcare | Jan 18, 2019 | SESE | | [K173576](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K173576.md) | 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 - DRTECH Corporation — 3 clearances - Fujifilm Medical System U.S.A., Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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