LungQ Software
Thirona CorporationLungQ by Thirona Corporation is a software tool that processes CT chest scans to help physicians quantitatively analyze pulmonary tissues. It performs 3D segmentation of lung regions, volumetric and density evaluations, fissure analysis, and generates reports to support diagnosis and monitoring of lung conditions.
Intended Use
The Thirona LungQ software provides CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LungQ software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, fissure evaluation, and reporting tools are provided.
Technology
LungQ is a standalone command-line software without a graphical user interface that analyzes CT thoracic images by performing 3D segmentation of lungs and lobes, volumetric and density measurements, fissure completeness analysis, and provides detailed reports to support clinical decision-making.
Performance
Verification testing included white box and system integration testing, and software validation used user scenarios. Equivalence testing compared LungQ outputs to the predicate device VIDA PW2 on 250 CT scans from COPDGene study, showing equivalent lung volume and density measurements. Fissure analysis performance was superior to a previous version with an AUC of 0.95 versus 0.76 in a 55 scan multicenter study.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/18/2017
5 months - 2
FDA Approval
6/5/2018
Other devices from Thirona Corporation
- LungQ v3.0.02024 • 510K
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