FDA.reportPublic FDA data

LungQ®

Primary DI
08719326703824
Brand
LungQ®
Company
Thirona B.V.
Model
LungQ 4
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.
Published
2026-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719326703824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719326703824087193267038248719326703824

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA 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).

Contacts#

Phone, Email table
PhoneEmail
+31(0)615523400helgasteinmann@thirona.eu

Regulatory Flags#

DUNS number
491292034
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719326703817LungQ®v3.y.z2025-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
17630039302051Remote ControlBracco Injeneering SAJAK2024-05-29
10810068810803Monarch Bronchscope 2.0/Monarch Platform (P2)Auris Health, Inc.JAK2024-05-05
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
37630039301980IV PoleBracco Injeneering SAJAK2024-03-01
37630039301997Floor StandBracco Injeneering SAJAK2024-03-01
10810068810766Monarch™ Software Tower v2.2.5Auris Health, Inc.JAK2024-02-16
10810068810773Monarch™ Software Cart v2.2.5Auris Health, Inc.JAK2024-02-16
10815411020793OmniTom Elite PCDNEUROLOGICA CORP.JAK2023-07-13