Product code MUJ: 510(k) clearances and predicates
Product code MUJ covers Virtual Cone (1.0). FDA lists 257 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
257 clearances on file under product code MUJ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 8 |
| 2023 | 10 |
| 2024 | 9 |
| 2025 | 10 |
| 2026 so far | 8 |
Recent clearances
Newest MUJ clearances in the FDA index, with applicant and decision date:
- K260750, Virtual Cone (1.0), applicant Varian Medical Systems, Inc., decided 2026-07-08. FDA record
- K253050, RadOncAI, applicant Informai, decided 2026-06-18. FDA record
- K260207, Multimodality Simulation Workspace (MM Sim) (v1.0.0), applicant Philips Medical Systems Nederland B.V., decided 2026-05-27. FDA record
- K252784, eXaSkin Plus, applicant Anatomical Geometry S.L., decided 2026-05-22. FDA record
- K253078, ART.1-US, applicant Seetreat Pty, Ltd., decided 2026-05-14. FDA record
- K252304, syngo.via RT Image Suite VC10, applicant Varian Medical Systems, Inc., decided 2026-03-18. FDA record
- K260308, TrueFit Bolus, applicant Adaptiiv Medical Technologies, Inc., decided 2026-02-19. FDA record
- K252002, Monaco RTP System (6.3), applicant Elekta Solutions AB, decided 2026-02-19. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include RadOncAI, Multimodality Simulation Workspace (MM Sim) (v1.0.0). Watch new MUJ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MUJ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MUJ clearances include Virtual Cone (1.0).
How many 510(k) clearances use product code MUJ?
257 at the time this page was generated, from openFDA records.
How do I find a predicate device under MUJ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MUJ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.