ProBeam 360 Proton Therapy System v3.0
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252815 FDA 510(k)
- FDA Product Code
- LHN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ProBeam 360 Proton Therapy System v3.0 is a charged-particle radiation therapy device designed for delivering precise proton beam treatments. It is classified as a Class II medical device under FDA regulations and operates using Intensity Modulated Proton Therapy (IMPT) to target tumors with high accuracy while minimizing exposure to surrounding healthy tissue.
This system is intended for use in radiation oncology departments and requires specialized infrastructure, including a proton therapy cyclotron and robotic patient positioning. Supplied as a comprehensive treatment solution, it integrates advanced imaging, treatment planning, and dynamic workflow capabilities. The device is regulated under FDA 510(k) clearance (K252815) and adheres to regulatory standards outlined in 21 CFR 892.5050, ensuring compliance with safety and performance requirements for charged-particle radiation therapy systems.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ProBeam 360 Proton Therapy System v3.0 (K252815) - Innolitics, ProBeam proton therapy system - Varian Oncology - PDF Catalogs ..., ProBeam Brochure - Varian Oncology - PDF Catalogs - MedicalExpo, ProBeam 360° - Proton therapy cyclotron with robotized positioning ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252815 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (1)
- FDA 510(k) K252815 24 fields · synced Oct 6, 2026