CT LVAS

GUDID 19356870000021

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.

4DMEDICAL LIMITED

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• Primary Device ID: 19356870000021
• NIH Device Record Key: 13217e63-1028-4864-abb3-ae28d79df4af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT LVAS
• Version Model Number: 1.x
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	19356870000021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232392

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: 2024-06-28
• Device Publish Date: 2024-06-20

Devices Manufactured by 4DMEDICAL LIMITED

• 19356870000021 - CT LVAS: 2024-06-28CT 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.
• 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