CT:VQ

GUDID 01935687000038

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.

4DMEDICAL LIMITED

CT system application software

• Primary Device ID: 01935687000038
• NIH Device Record Key: bc5d83ac-0eb8-4e53-822e-c1052b61e1eb
• Commercial Distribution Discontinuation: 2025-12-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CT:VQ
• Version Model Number: 2.2.0
• Company DUNS: 747517097
• Company Name: 4DMEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	01935687000038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251484

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-16
• Device Publish Date: 2025-12-08

Devices Manufactured by 4DMEDICAL LIMITED

• 01935687000038 - CT:VQ: 2025-12-16CT: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.
• 01935687000038 - CT:VQ: 2025-12-16 CT:VQ software is a non-invasive image post-processing technology, using CT lung images to provide clinical decision support for
• 19356870000021 - CT LVAS: 2024-06-28 CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quanti
• 19356870000014 - XV Lung Ventilation Analysis Software: 2021-01-26 The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images i