ProBeam 360 Proton Therapy System v3.0— 510(k) K252815
Substantially EquivalentVarian Medical Systems, Inc.
FDA 510(k) clearance K252815 for ProBeam 360 Proton Therapy System v3.0, Substantially Equivalent on 2026-04-23. Applicant: Varian Medical Systems, Inc.. Device class: 2.
Summary
Varian Medical Systems' ProBeam 360 Proton Therapy System v3.0 is filed under product code LHN (System, Radiation Therapy, Charged-Particle, Medical). The name carries a version designation, v3.0.
Class II, 21 CFR 892.5050. It came in as a Traditional 510(k), and Radiology is both the classification panel and the review panel.
Varian Medical Systems filed from Palo Alto, California. Review took 231 calendar days (September 4, 2025 to April 23, 2026).
Clearance details
- Applicant
- Varian Medical Systems, Inc.
- Product code
- Product code LHN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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