Intended Use

Used to plan radiotherapy treatments for patients with cancers of the head and neck, cervix, breast, and metastases to the brain using external beam photon irradiation and CT images. Creates contours and treatment plans that are imported into the user's own Treatment Planning System for review, editing, and dose recalculation.

Technology

Web-based contouring and radiotherapy treatment planning software that incorporates automated contouring using deep learning algorithms, automated plan optimization using Eclipse Treatment Planning features (e.g., Photon Optimizer, RapidPlan), and quality control checks. Plans are designed for specific cancers involving several anatomic regions and are meant to be imported for final review and dose calculation.

Performance

Performance testing included software verification and validation, multicenter clinical testing on large data sets from multiple anatomical regions and cancers, demonstrating safety and effectiveness comparable to the predicate Eclipse system, with contouring accuracy (DSC > 0.8 for 95% of scans), plan dose conformity within 5-7% of clinical plans, and isocenter localization within 3mm.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/8/2022

    8 months
  • 2

    FDA Approval

    5/17/2023

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.