# K051497: Vitesse 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 18, 2005 after 42 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 K992762 (2000). 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)
- K992762: Brachyvision 6.0, Varian Assoc., Inc. (2000) Summary page 1.

## Indications for use
Vitesse is a software application used to facilitate brachytherapy high dose rate treatment planning for patients with prostate cancer.

Source page: https://510kreport.com/device/K051497
Methodology: https://510kreport.com/methodology