Identity
- Trade Name
- LungQ® FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- v3.y.z FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719326703817 FDA UDI
- 510(k) Number
- K232412 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiology DICOM image processing application software
LungQ® by Thirona B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thirona B.V.
Sources (1)
- FDA UDI 1357b419-19c4-4b58-bf1c-bba1672e9f70 35 fields · synced May 30, 2026