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
JAK System, X-Ray, Tomography, Computed

GMDN Terms

Code Name
57812 Radiology DICOM image processing application software

Identifiers

Type ID
Primary 08719326703824

Customer Contacts