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510(k) Data Aggregation
K Number
K242919Device Name
V5med Lung AI
Manufacturer
V5med Inc.
Date Cleared
2025-03-27
(184 days)
Product Code
OEB, LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
V5med Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V5med Lung AI is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules (with diameter of 4-30 mm) during CT examinations of the chest for asymptomatic populations. This software provides adjunctive information to alert radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. It can be used in a concurrent read mode, where the AI analysis results are displayed alongside the original CT images during either the initial review or any subsequent reviews by the radiologist. V5med Lung AI does not replace the radiologist's critical judgment or diagnostic processes and should not be used in isolation from the original CT series.
Device Description
The V5med Lung AI is a software product designed to detect nodules in the lungs. The detection model is trained using a Deep Convolutional Neural Network (CNN) based algorithm, enabling automatic detection of lung nodules ranging from 4 to 30 mm in chest CT images.
The system integrates algorithm logic and database on the same server, ensuring simplicity and ease of maintenance. It accepts chest CT images from a PACS system, Radiological Information System (RIS), or directly from a CT scanner, analyzes the images, and provides output annotations regarding lung nodules.
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