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FDA-cleared K260509

AutoContour (RADAC V5)

Radformation, Inc.

Authorized purpose: AutoContour Model RADAC V5 assists radiation treatment planners with contouring and reviewing structures in medical images for radiation therapy treatment planning. It produces initial machine-learning contours for user review and modification; it does not independently approve a contour or treatment plan.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2026-03-19
FDA-cleared K242729

AutoContour (Model RADAC V4)

Radformation, Inc.

Authorized purpose: AutoContour Model RADAC V4 assists radiation treatment planners with contouring and reviewing structures in medical images for radiation therapy treatment planning. It generates initial machine-learning contours for user review and modification rather than independently approving contours or treatment plans.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-12-09
FDA-cleared K230685

AutoContour Model RADAC V3

Radformation, Inc.

Authorized purpose: AutoContour Model RADAC V3 assists radiation treatment planners with reviewed CT and MR contour generation, DICOM RT Structure Set export, and rigid or deformable registration; this release added 90 CT and 11 MR models.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-04-14
FDA-cleared K220598

AutoContour Model RADAC V2

Radformation, Inc.

Authorized purpose: AutoContour Model RADAC V2 assists radiation treatment planners with reviewed CT and MR contour generation, DICOM RT Structure Set export, and rigid or deformable registration; this release added 58 CT and six MR models.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-08-24
FDA-cleared K200323

AutoContour

Radformation, Inc.

AutoContour assists radiation treatment planners by generating initial structure contours from medical images for review and modification before radiation-therapy planning. The initial cleared release generated CT structure contours through a cloud service and returned DICOM RT Structure Sets for review, editing, and treatment-planning use.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-10-30