FDA UDI
In Commercial Distribution
🇺🇸 United States
LungQ®
DI: 08719326703824
·
Model: LungQ 4
·
Thirona B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LungQ®
- Primary DI
- 08719326703824
- Version / Model
- LungQ 4
- Company Name
- Thirona B.V.
- Labeler DUNS
- 491292034
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-12
- Public Version
- 1
- Public Version Date
- 2026-02-20
- Public Version Status
- New
- Public Device Record Key
- ce9ce3b6-76e2-48b4-a880-10497084a2b5
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719326703824 | GS1 |
Customer Contacts
- Phone
- +31(0)615523400
- [email protected]