XV Lung Ventilation Analysis Software

GUDID 19356870000014

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.

4DMEDICAL LIMITED

CT system application software

• Primary Device ID: 19356870000014
• NIH Device Record Key: 60f464f7-ee9c-41a7-a810-07892eb982ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XV Lung Ventilation Analysis Software
• Version Model Number: XV LVAS
• 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

Customer Support Contacts

• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com
• Phone: 18339872267
• Email: support@4DMedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	19356870000014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193293

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: 2021-01-26
• Device Publish Date: 2021-01-18

Devices Manufactured by 4DMEDICAL LIMITED

• 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: 2021-01-26The 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.
• 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