LungQ v3.0.0
Thirona BVLungQ v3.0.0 is a software tool that helps physicians analyze CT scans of the lungs by automatically segmenting lung structures, measuring lung volumes and densities, evaluating fissures, and generating reports. It supports diagnosis and monitoring of lung conditions by providing quantitative assessments from CT scans, streamlining clinical workflows.
Intended Use
The Thirona LungQ software provides reproducible CT values for pulmonary tissue essential for quantitative support in diagnosis and follow up of pulmonary abnormalities from CT thoracic datasets.
Technology
LungQ is a stand-alone command-line software that performs 3D segmentation and isolation of lung sub-compartments, volumetric and density analyses, fissure evaluation, and generates reports from CT datasets. It operates on Linux and supports DICOM data input.
Performance
Performance testing included compliance with FDA-recognized consensus standards, software verification and validation, human factors validation, and a substantial equivalence study comparing LungQ v3.0.0 with predicate LungQ v1.1.0. Results demonstrated equivalence in lung volume and density measurements, fissure evaluation, and overall safety and effectiveness without clinical testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/10/2023
5 months - 2
FDA Approval
1/8/2024
Other devices from Thirona BV
- LungQ Software2018 • 510K
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