Logo
RadAI Slice
Subscribe

Intended Use

The TeraRecon Neuro Algorithm is an algorithm for use by trained professionals to analyze dynamic brain perfusion image data acquired with CT or MRI, providing parameters related to brain tissue perfusion, vascular assessment, and tissue blood volume to assist in diagnosis and clinical decision support.

Technology

TeraRecon Neuro is a standalone software deployed as Windows executable or containerized application that processes brain perfusion images from DICOM-compliant CT or MRI scanners, performs motion correction, calculates multiple perfusion parameters and outputs 2D/3D visualizations and parametric maps, including time to peak, blood volume, blood flow, Tmax, penumbra/umbra maps. It is interoperable with PACS and third-party systems.

Performance

The device underwent software verification and validation per IEC 62304 and risk management per ISO 14971, passed all software tests, and was evaluated clinically through qualitative user evaluation comparing to predicate and reference devices with at least 85% substantial equivalence. Quantitative comparison of Tmax measurements was also performed, showing acceptable agreement. No new safety or effectiveness concerns were identified.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    2/7/2022

    6 months
  • 2

    FDA Approval

    8/12/2022

Other devices from TeraRecon, Inc

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.