CT:VQ
4Dmedical Limited
4DMEDICAL LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017426576 | 3017426576 | 4DMEDICAL LIMITED | 1 | N | 2026-01-01 | Level 7 Melbourne Connect, 700 Swanston Street Carlton Victoria AU 3053 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 278705 | 1090302805 | K251484 | CT:VQ | JAK | 2025-08-28 |
| 278705 | 1139076438 | K242467 | IQ-UIP | QWO | 2024-12-19 |
| 278705 | 1030286747 | K241847 | Imbio PHA (4.0.0) | QIH | 2024-08-30 |
| 278705 | 1921372045 | K232392 | CT Lung Ventilation Analysis Software (CT:V) | JAK | 2023-11-16 |
| 278705 | 1558544280 | K230112 | CAC Software | JAK | 2023-06-13 |
| 278705 | 1683534370 | K203256 | Imbio RV/LV Software | QIH | 2021-03-09 |
| 278705 | 1358717656 | K193293 | XV Lung Ventilation Analysis Software | JAK | 2020-05-14 |
| 278705 | 2063805708 | K180129 | Imbio Segmentation Editing Tool software | LLZ | 2018-03-16 |
| 278705 | 1819227114 | K141069 | Lung Density Analysis | JAK | 2014-09-17 |
Product Codes Associated With Registrations#
PMN#
CT Lung Ventilation Analysis Software (CT:V)
4Dmedical Limited
GUDID#
CAC - 3.1.x
2026-10-13
PHA - PHA The device is an interpretive software program that analyses chest x-ray or CT images to identify anatomical structures and provide quantitative measurements, such as RV/LV and Pa/Ao ratios. It is compatible with standard medical imaging formats (e.g. DICOM). Results are intended to support, not replace, clinical judgement. The device is not intended for use in Australia and is supplied for export only.
2026-10-13
IQ-UIP - 4DMedical’s IQ UIP software device uses a locked artificial intelligence algorithm to automatically analyze a qualifying chest computed tomography (CT) scan. The device performs image classification to identify if a chest CT scan contains findings suspicious for the radiological usual interstitial pneumonia (UIP) pattern and generates a summary output to report positive findings in parallel to and separate from the standard of care radiological image interpretation.
2026-10-13
LDA - LDA Lung Density Analysis Software LDA is a set of image post-processing algorithms that perform image segmentation, registration, thresholding and classification of CT images of human lungs.
2026-10-13
IQ-UIP - Imbio IQ-UIP is a computer-aided software indicated for use in notifying specialists associated with Interstitial Lung Disease (ILD) Centers of radiological findings suggestive of radiological Usual Interstitial Pneumonia (UIP) in non-contrast, chest CT scans of adults.
2026-05-10
CT:VQ - CT:VQ software is a non-invasive image post-processing technology, using CT lung images to provide clinical decisionsupport for thoracic disease diagnosis and management in adult patients. It utilizes two non-contrast chest CT studies toquantify and visualize ventilation and perfusion.Quantification and visualizations are provided as DICOM images. CT:VQ may be used when Radiologists,Pulmonologists, and/or Nuclear Medicine Physicians need a better understanding of a patient's lung function and/orrespiratory condition.
2026-01-28
CT:VQ - CT:VQ software is a non-invasive image post-processing technology, using CT lung images to provide clinical decisionsupport for thoracic disease diagnosis and management in adult patients. It utilizes two non-contrast chest CT studies toquantify and visualize ventilation and perfusion.Quantification and visualizations are provided as DICOM images. CT:VQ may be used when Radiologists,Pulmonologists, and/or Nuclear Medicine Physicians need a better understanding of a patient's lung function and/orrespiratory condition.
2025-12-08
CT LVAS - CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quantify and visualize regional and global ventilation within the lungs. The device provides physicians with additional clinical data to support management of pulmonary disease. Quantification and visualizations are provided in the form of a report.
2024-06-20
XV Lung Ventilation Analysis Software - The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images in combination with a CT image to quantify ventilation of pulmonary tissue, thereby providing support to physicians in their assessment of patients with lung diseases.The XV Lung Ventilation Analysis Software measures the tissue motion of the lung, at all locations throughout the lung, and at all phases of the breath. It uses these motion measurements to calculate the 4-dimensional (4D) ventilation of lung tissues. Quantification and statistics are provided in the form of a Report.The key outputs are:• The tidal volume (i.e. total lung ventilation), presented as a single value;• Visualization of lung ventilation with color-defined specific ventilation ranges;• The heterogeneity of lung ventilation, presented as three values; and• Ventilation graph/ histogram of the classified lung voxel’s relative frequencies including ventilation defect percentage.
2021-01-18