CT:VQ
4DMedical Limited
Product Details
Model Identifier
Manufacturer
4DMedical Limited
Product
CT:VQ
Version
Unknown
Date Cleared
08/28/2025
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Two non-contrast chest CT studies
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
CT:VQ software is a non-invasive image post-processing technology, using CT lung images to provide clinical decision support for thoracic disease diagnosis and management in adult patients. It utilizes two non-contrast chest CT studies to quantify 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/or respiratory condition.
Intended User
Radiologists, Pulmonologists, and/or Nuclear Medicine Physicians
Age
Adult
Anatomy
Chest
Modality
CT
Output
The device outputs DICOM images containing ventilation and perfusion output, consisting of a series of image slices generated with the same slice spacing as the expiration CT. In each slice, the intensity value for each voxel represents either the value of ventilation or the value for perfusion. Additional Information sheet is also generated containing quantitative data, such as lung volume.
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unknown
Age Range (Years)
Unknown
Sex (%)
- Female: Unknown
- Male: Unknown
- Unknown: Unknown
Output
Unknown
Race (%)
- White: Unknown
- Black or African American: Unknown
- American Indian or Alaska Native: Unknown
- Asian: Unknown
- Native Hawaiian or Other Pacific Islander: Unknown
- Unknown: Unknown
Ethnicity (%)
- Hispanic or Latino: Unknown
- Not Hispanic or Latino: Unknown
- Unknown: Unknown
Geographic Region (%)
- USA: Unknown
- International: Unknown
- Unknown: Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Performance
Study Type
Performance Testing Type
Both
Standalone Model Performance
Reference Standard (Ground Truth)
Unknown
No. of Cases
58
Age Range (Years)
Unknown
Sex (%)
- Female: Unknown
- Male: Unknown
- Unknown: Unknown
Race (%)
- White: Unknown
- Black or African American: Unknown
- American Indian or Alaska Native: Unknown
- Asian: Unknown
- Native Hawaiian or Other Pacific Islander: Unknown
- Unknown: Unknown
Ethnicity (%)
- Hispanic or Latino: Unknown
- Not Hispanic or Latino: Unknown
- Unknown: Unknown
Geographic Region (%)
- USA: Unknown
- International: Unknown
- Unknown: Unknown
Output
Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
Unknown
Model Specificity
Unknown
Reader Study Performance
No. of Readers
Unknown
No. of Cases
77
No. of Sites
Unknown
Output
Unknown
Age Range (Years)
Unknown
Sex (%)
- Female: Unknown
- Male: Unknown
- Unknown: Unknown
Race (%)
- White: Unknown
- Black or African American: Unknown
- American Indian or Alaska Native: Unknown
- Asian: Unknown
- Native Hawaiian or Other Pacific Islander: Unknown
- Unknown: Unknown
Ethnicity (%)
- Hispanic or Latino: Unknown
- Not Hispanic or Latino: Unknown
- Unknown: Unknown
Geographic Region (%)
- USA: Unknown
- International: Unknown
- Unknown: Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Accuracy
Unknown
Model Sensitivity
Unknown
Model Specificity
Unknown
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
Unknown
Slice Thickness
Unknown
Contrast Use
Unknown
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Predicate Device(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
4DMedical
Email
Additional Details
Related Use Cases
Unknown