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FDA-cleared K181572

Workflow Box

Mirada Medical Ltd.

Authorized purpose: Workflow Box is a software system for routing DICOM-compliant data to and from automated processing components. It supports atlas-based contouring, deformable-image-registration re-contouring, and machine-learning contouring for CT, MR, and RTSTRUCT data; contours may be used in clinical workflows including radiation-therapy treatment planning. Appropriate software must review and edit generated contours, and Workflow Box is not intended to automatically detect lesions.

Modality
Radiotherapy Planning Imaging
Anatomy
CT, MR, and RTSTRUCT imaging data for automated contours and radiotherapy planning
Decision
2018-07-10