MUJ — System, Planning, Radiation Therapy Treatment Class II
FDA Device Classification
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 |
|---|
| 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 |
| K252002 | elekta solutions | Monaco RTP System (6.3) | February 19, 2026 |
| K260308 | adaptiiv medical technologies | TrueFit Bolus | 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 |
| K240671 | xstrahl | XBeam (v2) | December 4, 2024 |