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510(k) Data Aggregation
K Number
K173821Device Name
LungQ Software
Manufacturer
Thirona Corporation
Date Cleared
2018-06-05
(169 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Thirona Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Lung Q 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, fissure 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 standalone command-line software which must be run from a command-line interpreter and does not have a graphical user interface.
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