# K241876: Vitesse (5.0)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Oct 23, 2024 after 117 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 1 generation back to K123152 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123152: Vitesse 3.0, Varian Medical Systems, Oncology Systems (2012) Summary page 5.

## Indications for use
Vitesse is indicated for use as a treatment planning software application used by medical professionals to plan,guide,optimize and document high-dose-rate brachytherapy procedures

Source page: https://510kreport.com/device/K241876
Methodology: https://510kreport.com/methodology