FDA product code MUE: Full Field Digital, System, X-Ray, Mammographic
MUE is the FDA product code for full field digital, system, x-ray, mammographic. It is a Class II device, regulated under 21 CFR 892.1715 and reviewed by the Radiology panel. FDA has cleared 56 510(k) submissions under MUE, 12 in the last five years, from 27 different applicants. The average 510(k) review took 184 days (median 162); 174 days on average over the last three years. 6 PMA applications cite this product code. FDA has posted 41 recalls for MUE devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Full Field Digital, System, X-Ray, Mammographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1715 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MUE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 141 |
| 2018 | 2 | 158 |
| 2019 | 2 | 104 |
| 2020 | 4 | 230 |
| 2021 | 4 | 209 |
| 2022 | 3 | 358 |
| 2023 | 1 | 381 |
| 2024 | 1 | 145 |
| 2025 | 3 | 203 |
| 2026 | 4 | 174 |
Compare with all 510(k) review times · Search every MUE clearance
Top MUE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| GE Healthcare | 9 | 2021-08-06 |
| Siemens Medical Solutions USA, Inc. | 7 | 2026-06-18 |
| Planmed OY | 4 | 2022-07-18 |
| DRTECH Corporation | 3 | 2023-01-26 |
| Fujifilm Medical Systems U.S.A, Inc. | 3 | 2017-10-27 |
22 more applicants have MUE clearances. See the full list in Caduvo.
Most recent MUE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254090 | Hologic, Inc. | I-View® | 2026-09-02 | 257 |
| K253678 | Siemens Medical Solutions USA, Inc. | MAMMOMAT B.brilliant (11372950) | 2026-06-18 | 209 |
| K254092 | Vieworks Co., Ltd. | Bellalun 2D (VDMS-1000S) | 2026-05-28 | 160 |
| K260087 | GE Medical Systems SCS | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | 2026-03-24 | 71 |
| K243420 | Genoray Co., Ltd. | HESTIA | 2025-07-17 | 255 |
Recalls for MUE devices
41 product recalls in 32 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-04-08.
| Year | Recalls |
|---|---|
| 2017 | 7 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2023 | 1 |
| 2025 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MUE?
MUE is the FDA product code for full field digital, system, x-ray, mammographic. It is a Class II device, regulated under 21 CFR 892.1715 and reviewed by the Radiology panel.
What device class is MUE?
Class II, regulation 21 CFR 892.1715. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUE?
Across 56 cleared submissions the average was 184 days from receipt to decision (median 162).
Which companies have the most MUE clearances?
GE Healthcare (9); Siemens Medical Solutions USA, Inc. (7); Planmed OY (4); DRTECH Corporation (3); Fujifilm Medical Systems U.S.A, Inc. (3).
Have MUE devices been recalled?
Yes: 41 product recalls across 32 recall events; the most recent began 2026-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code MUE
- Run a recall and safety report across every MUE manufacturer
- Watch product code MUE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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