Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Prepare with a buyer guide:

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K252304

syngo.via RT Image Suite VC10

Varian Medical Systems, Inc.

Authorized purpose: syngo.via RT Image Suite VC10 provides three-dimensional and four-dimensional multimodality visualization, registration, fusion, contouring, and planning support for radiation-treatment preparation.

Modality
Radiotherapy Planning Imaging
Anatomy
Brain, pelvis, thorax, abdomen, targets, organs at risk, and moving tumors or organs
Decision
2026-03-18
FDA-cleared K232923

Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)

Varian Medical Systems Inc.

Authorized purpose: Ethos Treatment Management 3.0 and Treatment Planning 2.0 manage radiotherapy sessions and create or modify traditional and adapted treatment plans for qualified professional review and approval.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-04-30
FDA-cleared K211881

AI Segmentation

Varian Medical Systems, Inc.

Authorized purpose: 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 approval in Eclipse treatment-planning workflows; it does not provide clinical decisions or evaluate treatment plans.

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

AI Segmentation

Varian Medical Systems, Inc.

Authorized purpose: 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 and approval in Eclipse treatment-planning workflows; this release does not include manual editing tools.

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.

Authorized purpose: Ethos Treatment Management is indicated for managing and monitoring radiation-therapy treatment plans and sessions. Ethos Treatment Planning is indicated for generating and modifying radiation-therapy treatment plans. The Halcyon and Ethos Radiotherapy System are indicated for delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.

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