# K133191: Probeam Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Jan 10, 2014 after 85 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963624 (1996). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101294: PT2 Varian Proton Therapy System, Varian Medical Systems, Oncology Systems (2010) Summary page 1.
- K042720: ON-Board Imager Device, Varian Medical Systems (2004) Summary page 1.

## Most influential descendants
- K221791: ProBeam 360°  Proton Therapy System (2022), 2 descendants of its own
- 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

## Recalls of this device
- May 9, 2014 · Class II · Z-1846-2014: Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.

## Indications for use
ProBeam 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/K133191
Methodology: https://510kreport.com/methodology