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XV Lung Ventilation Analysis Software

FDA UDI

Class II (US FDA UDI)

by 4Dmedical Limited

Identity

Trade Name
XV Lung Ventilation Analysis Software FDA UDI
Generic Name
CT system application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
XV LVAS FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
19356870000014 FDA UDI
510(k) Number
K193293 FDA UDI
FDA Product Code
JAK FDA UDI
GMDN Term
CT system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: CT system application software

XV Lung Ventilation Analysis Software by 4Dmedical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CT system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
4Dmedical Limited

Sources (1)

  • FDA UDI 60f464f7-ee9c-41a7-a810-07892eb982ca 35 fields · synced May 30, 2026