ProBeam 360 Proton Therapy System v3.0
Device Facts
| Record ID | K252815 |
|---|---|
| Device Name | ProBeam 360 Proton Therapy System v3.0 |
| Applicant | Varian Medical Systems, Inc. |
| Product Code | LHN · Radiology |
| Decision Date | Apr 23, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
