FDA product code MUJ: System, Planning, Radiation Therapy Treatment
MUJ is the FDA product code for system, planning, radiation therapy treatment. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. FDA has cleared 252 510(k) submissions under MUJ, 40 in the last five years, from 91 different applicants. The average 510(k) review took 116 days (median 87); 170 days on average over the last three years. FDA has posted 265 recalls for MUJ devices, 59 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Planning, Radiation Therapy Treatment |
| Device class | Class II |
| Regulation | 21 CFR 892.5050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for MUJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 58 |
| 2018 | 7 | 75 |
| 2019 | 9 | 84 |
| 2020 | 9 | 96 |
| 2021 | 11 | 101 |
| 2022 | 8 | 186 |
| 2023 | 10 | 153 |
| 2024 | 9 | 149 |
| 2025 | 10 | 195 |
| 2026 | 3 | 165 |
Top MUJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Varian Medical Systems, Inc. | 26 | 2026-03-18 |
| RaySearch Laboratories AB (PUBL) | 15 | 2025-12-22 |
| Siemens Medical Solutions USA, Inc. | 13 | 2024-04-26 |
| Brainlab AG | 11 | 2025-06-17 |
| Computerized Medical Systems, Inc. | 9 | 2011-06-24 |
86 more applicants have MUJ clearances. See the full list in Caduvo.
Most recent MUJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252304 | Varian Medical Systems, Inc. | syngo.via RT Image Suite VC10 | 2026-03-18 | 237 |
| K260308 | Adaptiiv Medical Technologies, Inc. | TrueFit Bolus | 2026-02-19 | 20 |
| K252002 | Elekta Solutions AB | Monaco RTP System (6.3) | 2026-02-19 | 237 |
| K253091 | Therapanacea Sas | ART-Plan+ (v3.1.0) | 2025-12-23 | 91 |
| K252109 | RaySearch Laboratories AB (PUBL) | RayStation (2024A SP3) | 2025-12-22 | 168 |
Recalls for MUJ devices
265 product recalls in 199 recall events; 59 initiated in the last five years and 71 still open. Most recent: 2025-12-12.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 7 |
| 2019 | 10 |
| 2020 | 30 |
| 2021 | 15 |
| 2022 | 6 |
| 2023 | 5 |
| 2024 | 13 |
| 2025 | 33 |
Frequently asked questions
What is FDA product code MUJ?
MUJ is the FDA product code for system, planning, radiation therapy treatment. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.
What device class is MUJ?
Class II, regulation 21 CFR 892.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUJ?
Across 252 cleared submissions the average was 116 days from receipt to decision (median 87).
Which companies have the most MUJ clearances?
Varian Medical Systems, Inc. (26); RaySearch Laboratories AB (PUBL) (15); Siemens Medical Solutions USA, Inc. (13); Brainlab AG (11); Computerized Medical Systems, Inc. (9).
Have MUJ devices been recalled?
Yes: 265 product recalls across 199 recall events; the most recent began 2025-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MUJ
- Run a recall and safety report across every MUJ manufacturer
- Watch product code MUJ 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.