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510(k) Data Aggregation
K Number
K232412Device Name
LungQ v3.0.0
Manufacturer
Date Cleared
2024-01-08
(151 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Thirona BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Thirona LungQ software provides reproducible 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 evaluation, and reporting tools are provided.
Device Description
The LungQ software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. LungQ is stand-alone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.
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