qXR-BT
Qure.ai TechnologiesqXR-BT by Qure.ai Technologies is an AI-powered software designed to analyze chest X-ray images to help physicians confirm the position of breathing tubes. It generates secondary digital images with highlighted tube tips and anatomical landmarks, providing valuable adjunctive information during radiological assessment.
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
Device Timeline
- 1
Submission
8/25/2021
3 months - 2
FDA Approval
12/21/2021
Other devices from Qure.ai Technologies
- qCT LN Quant2024 • 510K
- qXR-LN2023 • 510K
- qXR-CTR2023 • 510K
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