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

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Primary Device ID19356870000014
NIH Device Record Key60f464f7-ee9c-41a7-a810-07892eb982ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameXV Lung Ventilation Analysis Software
Version Model NumberXV LVAS
Company DUNS747517097
Company Name4DMEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com
Phone18339872267
Emailsupport@4DMedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS119356870000014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18
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