MUJ — System, Planning, Radiation Therapy Treatment Class II
FDA product code MUJ covers "System, Planning, Radiation Therapy Treatment", a Class II medical device regulated under 21 CFR 892.5050. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MUJ
- Device Class
- Class II
- Regulation Number
- 892.5050
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260750 | varian medical systems | Virtual Cone (1.0) | July 8, 2026 |
| K253050 | informai | RadOncAI | June 18, 2026 |
| K260207 | philips medical systems nederland | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | May 27, 2026 |
| K252784 | anatomical geometry s.l | eXaSkin Plus | May 22, 2026 |
| K253078 | seetreat pty | ART.1-US | May 14, 2026 |
| K252304 | varian medical systems | syngo.via RT Image Suite VC10 | March 18, 2026 |
| K260308 | adaptiiv medical technologies | TrueFit Bolus | February 19, 2026 |
| K252002 | elekta solutions | Monaco RTP System (6.3) | February 19, 2026 |
| K253091 | therapanacea | ART-Plan+ (v3.1.0) | December 23, 2025 |
| K252109 | raysearch laboratories ab (publ) | RayStation (2024A SP3) | December 22, 2025 |
| K252863 | radformation | ClearCalc Model RADCA V2.6 | December 19, 2025 |
| K250963 | cosylab jsc, control system laboratory | PlanOne 1 | November 20, 2025 |
| K250064 | mvision ai | Dose+ (1.0) | September 4, 2025 |
| K250440 | brainlab | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; | June 17, 2025 |
| K242992 | raysearch laboratories ab (publ) | RayCare (2024A SP1) | April 17, 2025 |
| K242748 | oncospace | Oncospace | April 11, 2025 |
| K240398 | raysearch laboratories ab (publ) | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 202 | April 4, 2025 |
| K242822 | therapanacea | ART-Plan+ (v.3.0.0) | February 25, 2025 |
| K242463 | varian medical systems | ARIA Radiation Therapy Management System (18.1) | December 13, 2024 |
| K242378 | varian medical systems | Eclipse Treatment Planning System (18.1) | December 11, 2024 |