LungQ®

GUDID 08719326703817

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 CT thoracic datasets. Analysis provided includes segmentation and isolation of sub-compartments, volumetric analysis, tissue destruction, density evaluations, airway and vessel evaluation, fissure evaluation and reporting tools.

Thirona B.V.

Radiology DICOM image processing application software

• Primary Device ID: 08719326703817
• NIH Device Record Key: 1357b419-19c4-4b58-bf1c-bba1672e9f70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LungQ®
• Version Model Number: v3.y.z
• Company DUNS: 491292034
• Company Name: Thirona B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu
• Phone: +31(0)615523400
• Email: helgasteinmann@thirona.eu

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719326703817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232412

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-01
• Device Publish Date: 2025-04-23