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Intended Use

The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

Technology

The software is a set of medical image post-processing algorithms that perform automated image segmentation and diameter measurements on CT pulmonary angiography images. It reads DICOM CTPA datasets and outputs DICOM images with color-coded caliper measurements and a PDF report. It operates as a command-line executable program and integrates into existing radiological workflows without direct interfacing to CT scanners.

Performance

Clinical performance testing included two reader studies demonstrating that the software improves agreement among radiologists and accurately measures RV/LV diameter ratios compared to radiologist measurements. Anonymized CTPA datasets were used.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/4/2020

    4 months
  • 2

    FDA Approval

    3/9/2021

Other devices from Imbio, LLC

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