CT:VQ

Basic Information

• Brand Name: CT:VQ
• Primary DI: 01935687000038
• Version / Model: 2.2.0
• Company Name: 4DMEDICAL LIMITED
• Labeler DUNS: 747517097
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-08
• Public Version: 2
• Public Version Date: 2026-01-29
• Public Version Status: Update
• Public Device Record Key: bc5d83ac-0eb8-4e53-822e-c1052b61e1eb
• Distribution End Date: 2026-01-28

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40867	CT system application software	An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	01935687000038	GS1

Premarket Submissions

Submission Number	Supplement Number
K251484	000