FDA product code · Radiology
MUJSystem, Planning, Radiation Therapy Treatment
Product code MUJ covers System, Planning, Radiation Therapy Treatment, a Class II device regulated under 21 CFR 892.5050. FDA has cleared 257 devices in this code, 13 of them in the last 12 months. Median review time across the 257 most recent decisions is 88 days. openFDA lists 267 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.5050
- Review panel
- Radiology
- Clearances
- 257
What is happening in MUJ right now?
MUJ (System, Planning, Radiation Therapy Treatment) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2646-2026, Z-2647-2026, Z-1339-2026, Z-1340-2026, Z-1102-2026). 6 first-time filers in the last 12 months, including Informai and Philips Medical Systems Nederland B.V (K253050, K260207, K252784, K253078, K250963). Clearances are running 165% slower — a median 233 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days) (MUJ:review_time:12m). The code is crowded, scoring 90 of 100 — 86 companies hold a clearance here and 13 arrived in the last 12 months (MUJ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2646-2026, Z-2647-2026, Z-1339-2026, Z-1340-2026, Z-1102-2026 |
| New entrant | Worth knowing | K253050, K260207, K252784, K253078, K250963 |
| Review time | Context | MUJ:review_time:12m |
| Crowding | Context | MUJ:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in MUJ?
FDA has cleared 257 devices under product code MUJ since the 510(k) programme began in 1976, 13 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260750 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | |
| K253050 | RadOncAI | Informai | |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | |
| K252784 | eXaSkin Plus | Anatomical Geometry S.L. | |
| K253078 | ART.1-US | Seetreat Pty, Ltd. | |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) |
How long does FDA review take for MUJ?
The median FDA review time for MUJ is 88 days, measured across the 257 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MUJ?
openFDA lists 267 recall records against product code MUJ. A recall record covers one firm's corrective action and may span many device lots.
Z-2646-2026Open, ClassifiedRAYSEARCH LABORATORIES AB
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Z-2647-2026Open, ClassifiedRAYSEARCH LABORATORIES AB
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Z-1339-2026Open, ClassifiedElekta Limited
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Z-1340-2026Open, ClassifiedElekta Limited
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Z-1102-2026Open, ClassifiedRAYSEARCH LABORATORIES AB
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Showing the 5 most recently initiated of 267. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MUJ?
MAUDE holds 102 adverse-event reports naming product code MUJ, 12 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MUJ unusual?
MUJ does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 46 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered MUJ in the last year?
6 companies filed in MUJ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Informai | K253050 | |
| Philips Medical Systems Nederland B.V. | K260207 | |
| Anatomical Geometry S.L. | K252784 | |
| Seetreat Pty, Ltd. | K253078 | |
| Cosylab Jsc, Control System Laboratory | K250963 | |
| Mvision AI OY | K250064 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in MUJ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MUJ?
Across the 257 most recent decisions, these applicants filed most often in MUJ.
| Applicant | Recent clearances |
|---|---|
| Varian Medical Systems, Inc. | 27 |
| RaySearch Laboratories AB (PUBL) | 15 |
| Siemens Medical Solutions USA, Inc. | 13 |
| Brainlab AG | 11 |
| Computerized Medical Systems, Inc. | 9 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in MUJ file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Varian Medical Systems, Inc. | 33 | 2 |
| Nucletron BV | 12 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MUJ
Get an email the morning anything changes in MUJ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.