# K221791: ProBeam 360°  Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Dec 1, 2022 after 163 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: 5 generations back to K963624 (1996). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133191: Probeam Proton Therapy System, Varian Medical Systems (2014) Summary page 4.
- K160518: LEONI ORION System, Leoni Cia Cable System (2016) Summary page 6.

## Most influential descendants
- K231863: ProBeam 360° Proton Therapy System v2.0 (Multiroom) (2023), 1 descendant of its own
- K252815: ProBeam 360 Proton Therapy System v3.0 (2026), 0 descendants of its own

## Indications for use
The 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/K221791
Methodology: https://510kreport.com/methodology