Vitesse (5.0)
Varian Medical SystemsVitesse (5.0) is a treatment planning software designed for medical professionals to assist in planning, guiding, optimizing, and documenting high-dose-rate brachytherapy procedures. It supports real-time ultrasound guidance, image import and export via DICOM standards, and visualization of complex imaging data including PET and MR scans. This software helps clinicians create and manage radiation treatment plans accurately and efficiently, improving patient care in radiation therapy.
Intended Use
Vitesse is intended for use as a treatment planning software application used by medical professionals to plan, guide, optimize and document high-dose-rate brachytherapy procedures.
Technology
Vitesse 5.0 is a stand-alone software application providing treatment planning features for high dose rate brachytherapy, supporting real-time ultrasound guided implant procedures and image import/export workflows based on DICOM RT standards. The software includes tools for visualization, DICOM C-STORE and C-FIND network export/import, and supports PET and enhanced MR image volumes and color imaging modes. It includes user authentication and enhanced usability features.
Performance
Performance testing includes software verification and validation demonstrating that device requirements and risk controls perform as intended at a level similar to the predicate device. Cybersecurity and interoperability compliance were verified, usability testing according to IEC 62366 was performed, and no clinical or animal testing was conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2024
3 months - 2
FDA Approval
10/23/2024
Other devices from Varian Medical Systems
- Gating Reflector Block2024 • 510K
- Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)2024 • 510K
- AI Segmentation2021 • 510K
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