FDA.reportPublic FDA data

THIRONA BV

Matched from indexed company URL: Thirona B.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146538003014653800THIRONA BV1N2026-01-01Toernooiveld 300 Nijmegen Gelderland NL 6525 EC

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08719326703817LungQ® - The LungQ software produces reproducible CT values for pulmonary tissue, providing quantitative support for diagnosis, selection of patients for treatment, treatment planning,and follow-up examinations. LungQ can be used to support the physician in the diagnosis, evaluation and documentation of pulmonary tissue images (e.g. abnormalities) from CTthoracic datasets. Analysis provided includes segmentation and isolation of sub-compartments, volumetric analysis, tissue destruction, density evaluations, airway andvessel evaluation, fissure evaluation and reporting tools.+31(0)615523400helgasteinmann@thirona.eu
08719326703824LungQ® - The Thirona LungQ software provides reproducible CT values for pulmonary tissue and specified endobronchial implants which is essential for providing quantitative support for diagnosis, treatment planning 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, estimated chronic perfusion defect analysis, fissure evaluation and reporting tools are provided.+31(0)615523400helgasteinmann@thirona.eu

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2199011167650270K250766LungQ 4JAK2025-10-02
2199011468077434K232412LungQ v3.0.0JAK2024-01-08
2199011224088058K173821LungQ SoftwareJAK2018-06-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK32025-10-02

PMN#

GUDID#

LungQ® - The Thirona LungQ software provides reproducible CT values for pulmonary tissue and specified endobronchial implants which is essential for providing quantitative support for diagnosis, treatment planning 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, estimated chronic perfusion defect analysis, fissure evaluation and reporting tools are provided.

Thirona B.V.

2026-02-12

LungQ® - The LungQ software produces reproducible CT values for pulmonary tissue, providing quantitative support for diagnosis, selection of patients for treatment, treatment planning,and follow-up examinations. LungQ can be used to support the physician in the diagnosis, evaluation and documentation of pulmonary tissue images (e.g. abnormalities) from CTthoracic datasets. Analysis provided includes segmentation and isolation of sub-compartments, volumetric analysis, tissue destruction, density evaluations, airway andvessel evaluation, fissure evaluation and reporting tools.

Thirona B.V.

2025-04-23