Workflow Box
Mirada Medical Ltd.Workflow Box by Mirada Medical Ltd is a software system that helps route medical imaging data and automatically applies contouring to images like CT and MRI. It uses advanced methods including deformable image registration and machine learning to assist clinicians in creating detailed anatomical outlines for radiation therapy planning. The software integrates with other visualization tools to allow medical professionals to review and adjust automatically generated contours.
Intended Use
Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components including processing components for automatically contouring imaging data using deformable image registration and machine learning-based algorithms. It supports CT, MR, RTSTRUCT modalities and is intended to augment clinical workflows including radiation therapy treatment planning.
Technology
Workflow Box is a server-based software application that routes image data and structures for automated image processing workflows. It implements atlas based contouring, deformable image registration, and machine learning based contouring. It processes DICOM CT, MR, and RTSTRUCT images and integrates with hospital DICOM nodes. The software has no visualization interface and requires other applications for contour review and editing.
Performance
Validation and verification testing including performance, functional, and algorithmic tests were conducted demonstrating that the device meets user needs and intended use, and is substantially equivalent to its predicate device. Testing was performed in compliance with CFR 21 Part 820 and DICOM standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/14/2018
26 days - 2
FDA Approval
7/10/2018
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.