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510(k) Data Aggregation

    K Number
    K240554
    Device Name
    InferRead Lung CT.AI
    Manufacturer
    Infervision Medical Technology Co., Ltd.
    Date Cleared
    2025-05-16

    (443 days)

    Product Code
    OEB, QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Infervision Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules ≥ 4mm during the review of CT examinations of the chest on an asymptomatic population ≥ 55 years old. InferRead Lung CT.AI requires that both lungs be in the field of view. InferRead Lung CT.AI provides adjunctive information and is not intended to be used without the original CT series.
    Device Description
    InferRead Lung CT.AI uses the deep learning (DL) technology to perform nodule detection. It is a dedicated post-processing application that generates CADe marks as an overlay on original CT scans. The software can be installed in a healthcare facility or a cloud-based platform and is comprised of computer-assisted reading tools designed to aid radiologists in detecting, segmenting, measuring and localizing actionable pulmonary nodules that are 4mm or above during the review of chest CT examinations of asymptomatic populations, with enhanced capabilities for pulmonary nodule follow-up comparison and lung analysis. InferRead Lung CT.AI provides auxiliary information and is not intended to be used if the original CT series is not available.
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    K Number
    K211179
    Device Name
    InferRead CT Stroke.AI
    Manufacturer
    Infervision Medical Technology Co., Ltd.
    Date Cleared
    2021-08-12

    (114 days)

    Product Code
    QAS
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Infervision Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of Non-Enhanced Head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH). InferRead CT Stroke.AI uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with a worklist with marked cases of suspected ICH findings. The device does not alter the original medical image, does not remove cases from queue, and is not intended to be used as a diagnostic device. If the clinician does not view the case, or if a case is not flagged, cases remain to be processed per the standard of care. The results of InferRead CT Stroke.AI are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
    Device Description
    InferRead CT Stroke.AI is a radiological computer-assisted triage and notification software device. The software device is a computer program with a deep learning algorithm running on Ubuntu operating system. The device can be deployed as an onsite server in the hospital and the user interacts with the software from a client workstation. The device can be broken down into 4 modules, the NeoViewer, Docking Toolbox, RePACS, and DLServer. The Docking Toolbox module receives DICOM series and inspects the series against a list of requirements. Series that pass the requirements are sent into the system for prediction for intracranial hemorrhage. Series are processed in a first-out order. When hemorrhage is detected, the system marks the case in the work list prompting the user to conduct preemptive triage and prioritization. When the user refreshes the page, cases with suspected findings will be marked with an indicator. Cases are identified, such as by Name and Patient ID. A preview is available but is not intended for primary diagnosis and a radiologist must review the case per their standard process. The suspected cases assist in triaging intracranial hemorrhage cases sooner than standard of care practice alone.
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