TeraRecon Cardiac.Chambers.MR (1.0.0)
TeraRecon,Inc.TeraRecon Cardiac.Chambers.MR is a software tool designed to automatically segment the anatomical structures of cardiac chambers from contrast or non-contrast cardiac MR scans in adult patients. It helps clinicians by providing precise delineation of the left and right ventricular walls, facilitating faster and more accurate cardiac assessment.
Intended Use
This medical device is intended to segment Cardiac chambers as anatomical structures on contrast or non-contrast MR scans of adult patients that undergo Cardiac MR procedures. The algorithm is not specific to any gender or ethnic group or clinical conditions.
Technology
The device is a containerized software application using supervised deep learning-based algorithms to automatically detect and segment left ventricular and right ventricular myocardium and chambers from DICOM-compliant cardiovascular MR images acquired by various MR scanners.
Performance
Clinical validation was performed on a retrospective cohort of 100 adult patients (50 each for Cine-ax and De-ax algorithms) from multiple scanner manufacturers (GE, Philips, Siemens) with artifact exclusion criteria. Segmentation accuracy was assessed using Dice similarity coefficients exceeding predefined thresholds across diverse patient demographics and imaging conditions, demonstrating safety and efficacy equivalent to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/9/2024
6 months - 2
FDA Approval
11/5/2024
Other devices from TeraRecon,Inc.
- TeraRecon Neuro2022 • 510K
- Neuro.Al Algorithm2020 • 510K
- iNtuition-Structural Heart Module2019 • 510K
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