AccessGUDID - DEVICE: LungQ® (08719326703817)

GUDID

Device Identifier (DI) Information

Brand Name: LungQ®
Version or Model: v3.y.z
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thirona B.V.

Primary DI Number: 08719326703817
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 491292034 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232412	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1357b419-19c4-4b58-bf1c-bba1672e9f70
Public Version Date: May 01, 2025
Public Version Number: 1
DI Record Publish Date: April 23, 2025