FDA product code · Radiology · Class 2
MUJ: System, Planning, Radiation Therapy Treatment
MUJ is FDA's product code for "System, Planning, Radiation Therapy Treatment": a Class 2 device classified under 21 CFR 892.5050, reviewed by the Radiology panel.
510(k) review time for MUJ
Across 81 510(k) clearances under MUJ decided from 2018-01-01 to 2026-10-06, the median was 123 days from FDA receipt to decision. Half took between 77 and 197 days, and 80% were decided within 211 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 77 |
| Median | 123 |
| 75th percentile | 197 |
| 80th percentile | 211 |
| 90th percentile | 237 |
| Slowest | 437 |
| Year | Median days | n |
|---|---|---|
| 2018 | 53 | 7 |
| 2019 | 56 | 9 |
| 2020 | 104 | 9 |
| 2021 | 87 | 11 |
| 2022 | 168 | 8 |
| 2023 | 140 | 10 |
| 2024 | 122 | 9 |
| 2025 | 186 | 10 |
| 2026 (to 10-06, partial) | 235 | 8 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MUJ in the public FDA record
| 510(k) clearances, all years | 257 |
|---|---|
| Device recalls | 267 |
| Establishment listings | 169 |
Counts of records, not of devices or events. Adverse event reports for MUJ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MUJ
6 FDA recognized consensus standards cite MUJ, among them IEC 62083 Edition 2.0 2009-09; IEC 60601-2-11 Edition 3.0 2013-01; IEC 61217 Edition 2.0 2011-12. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-217 IEC 62083 Edition 2.0 2009-09 — Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
- 12-255 IEC 60601-2-11 Edition 3.0 2013-01 — Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
- 12-267 IEC 61217 Edition 2.0 2011-12 — Radiotherapy equipment - Coordinates movements and scales
- 12-304 IEC 60731 Edition 3.1 2016-04 — Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
- 12-307 AAMI RT2:2017 — Radiation therapy readiness check
- 12-338 IEC 60601-2-1 Edition 4.0 2020-10 — Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.