# K101294: PT2 Varian Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Oncology Systems
- Decided: Dec 27, 2010 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: 2 generations back to K872369 (1988). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082416: Iba Proton Therapy System- Proteus 235, Ion Beam Applications S.A. (2008) Summary page 1.

## Most influential descendants
- K120676: S-250 Proton Beam Radiation Therapy System (2012), 5 descendants of its own
- K152224: Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) (2016), 4 descendants of its own
- K133191: Probeam Proton Therapy System (2014), 3 descendants of its own
- K221791: ProBeam 360°  Proton Therapy System (2022), 2 descendants of its own
- K172848: MEVION S250i Proton Beam Radiation Therapy Device (2017), 2 descendants of its own

## Indications for use
PT2 Varian 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/K101294
Methodology: https://510kreport.com/methodology