Intended Use

The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest X-rays. It provides adjunctive information and is not a substitute for the original PA/AP image.

Technology

qXR-BT is a standalone image analysis software that integrates with existing PACS and radiology workflow. It uses pre-trained convolutional neural networks (CNNs) for image processing, taking DICOM format digital chest X-rays as input and producing secondary annotated DICOM series and PDF reports with location of breathing tube tips and anatomical landmarks.

Performance

Performance testing using 162 chest X-ray images showed that the device accurately localized the carina and tip of the breathing tube with mean absolute distances around 2 mm, meeting preset acceptance criteria. The device also passed software verification and validation testing.

Predicate Devices

No predicate devices specified

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