← Product Code [MUJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/MUJ) · K123152

# VITESSE 3.0 (K123152)

_Varian Medical Systems, Oncology Systems · MUJ · Dec 7, 2012 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/MUJ/K123152

## Device Facts

- **Applicant:** Varian Medical Systems, Oncology Systems
- **Product Code:** [MUJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/MUJ.md)
- **Decision Date:** Dec 7, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5050
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/MUJ/K123152](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/MUJ/K123152)

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