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/productcode/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 60)

Showing 20 most recent of 60 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K254092](/device/K254092.md) | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | May 28, 2026 | SESE |
| [K260087](/device/K260087.md) | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | Mar 24, 2026 | SESE |
| [K243420](/device/K243420.md) | HESTIA | Genoray Co., Ltd. | Jul 17, 2025 | SESE |
| [K243849](/device/K243849.md) | 2430TCA with Xmaru W | Rayence Co., Ltd. | Mar 12, 2025 | SESE |
| [K241113](/device/K241113.md) | VIVIX-M | Vieworks Co., Ltd. | Jan 16, 2025 | SESE |
| [K233539](/device/K233539.md) | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | Mar 27, 2024 | SESE |
| [K220073](/device/K220073.md) | RMF-2000 | DRTECH Corporation | Jan 26, 2023 | SESE |
| [K211720](/device/K211720.md) | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | Jul 18, 2022 | SESE |
| [K212873](/device/K212873.md) | Aspire Cristalle | Fujifilm Corporation | May 27, 2022 | SESE |
| [K210151](/device/K210151.md) | Digimamo D | Vmi Tecnologias Ltda | Mar 1, 2022 | SESE |
| [K202822](/device/K202822.md) | Helianthus | Metaltronica Spa | Dec 15, 2021 | SESE |
| [K211725](/device/K211725.md) | Senographe Pristina | GE Healthcare | Aug 6, 2021 | SESE |
| [K211215](/device/K211215.md) | SenoBright HD | GE Healthcare | Jun 22, 2021 | SESE |
| [K202902](/device/K202902.md) | 2430MCA with Xmaru W | Rayence Co., Ltd. | Jun 21, 2021 | SESE |
| [K192317](/device/K192317.md) | Planmed Clarity 2D and Clarity S | Planmed OY | Oct 23, 2020 | SESE |
| [K200424](/device/K200424.md) | Giotto Class (Models - 3000X-YY and 4000X-YY) | Ims Giotto S.P.A. | Jun 18, 2020 | SESE |
| [K193166](/device/K193166.md) | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | Jun 12, 2020 | SESE |
| [K193334](/device/K193334.md) | Pristina Serena Bright | GE Healthcare | May 15, 2020 | SESE |
| [K190809](/device/K190809.md) | Sample Imaging for Senographe Pristina | GE Healthcare | Jul 29, 2019 | SESE |
| [K182951](/device/K182951.md) | Pristina Serena 3D | GE Healthcare | Jan 18, 2019 | 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

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**Source:** [https://fda.innolitics.com/productcode/MUE](https://fda.innolitics.com/productcode/MUE)

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