# K093250: Proton Therapy Multileaf Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Dec 24, 2009 after 69 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: 4 generations back to K926449 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050442: Millennium Multi-Leaf Collimator, Varian Medical Systems (2005) Summary page 1.

## Most influential descendants
- K152207: Extended Range Shifter for PROBEAT-V (2015), 0 descendants of its own

## Indications for use
The Varian Proton Therapy Multileaf Collimator is an accessory radiation collimator intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Source page: https://510kreport.com/device/K093250
Methodology: https://510kreport.com/methodology
