FDA-cleared K252304

syngo.via RT Image Suite VC10

Varian Medical Systems, Inc.

syngo.via RT Image Suite VC10 provides three-dimensional and four-dimensional multimodality visualization, registration, fusion, contouring, and planning support for...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain, pelvis, thorax, abdomen, targets, organs at risk, and moving tumors or organs
Decision
2026-03-18
FDA-cleared K211881

AI Segmentation

Varian Medical Systems, Inc.

AI Segmentation version 2.0 is a cloud web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review, editing, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-09-02
FDA-cleared K203469

AI Segmentation

Varian Medical Systems, Inc.

AI Segmentation version 1.0 is a static, cloud-hosted web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-04-19
FDA-cleared K192377

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

Varian Medical Systems, Inc.

Ethos Treatment Management is indicated for managing and monitoring radiation-therapy treatment plans and sessions. Ethos Treatment Planning is indicated for generating and...

Modality
Radiotherapy Planning Imaging
Anatomy
Lesions, tumors, and conditions anywhere in the body; radiation-treatment plans and sessions
Decision
2020-02-10