# K252815: ProBeam 360 Proton Therapy System v3.0

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Apr 23, 2026 after 231 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963624 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221791: ProBeam 360°  Proton Therapy System, Varian Medical Systems, Inc. (2022) Summary page 5.
- K231863: ProBeam 360° Proton Therapy System v2.0 (Multiroom), Varian Medical Systems, Inc. (2023) Summary page 5.

## Indications for use
ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K252815
Methodology: https://510kreport.com/methodology