4dmedical.comCT: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 |
| 3017494490 | 3017494490 | 4DMedical USA Inc. | 1 | Y | 2026-01-01 | 21255 Burbank Blve. Suite 120 Woodland Hills CA US 91367 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 19356870000014 | 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. | 18339872267 | support@4DMedical.com |
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#
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