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510(k) Data Aggregation

    K Number
    K253008

    Validate with FDA (Live)

    Device Name
    maiLink
    Manufacturer
    Date Cleared
    2026-01-05

    (108 days)

    Product Code
    Regulation Number
    892.2050
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K211733, K211678, K241439, K243696, K201710, K212365

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    maiLink, a PACS and radiology workflow management software available as both a desktop/laptop application and a web viewer, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, secondary capture tools, imaging gateways. maiLink enables the storage, transmission, processing, and visualization of images and data within the system itself or over computer networks spanning different locations. Only pre-processed DICOM images specifically intended for presentation are suitable for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the maiLink. To ensure accurate interpretation, mammographic images should only be evaluated on a monitor that adheres to the technical specifications outlined by the FDA. This system is designed exclusively for use by proficient and certified medical experts, including physicians, radiologists, and medical technicians.

    Device Description

    maiLink is software designed to receive and transmit medical images from various medical imaging devices through SDK, DICOM communication, or user image uploads. It sends these images to an AI medical imaging reading solution software, receives the interpretation results, and allows for storage or transmission to the hospital's PACS system. maiLink acts as an intermediary service between medical imaging modalities and AI-assisted reading solutions.

    The medical imaging devices and AI medical imaging reading solution software are not included in this product and require separate authorization. This product complies with the DICOM standard protocol, a standard for medical imaging, to facilitate integration with PACS for the storage and communication of medical images.

    maiLink's integrated FDA-cleared algorithm list is exclusively managed by maiLink. AI Customers do not have the ability technically or administratively to add or modify which FDA-cleared AI algorithms are integrated with maiLink. Only FDA-cleared algorithms which have passed rigorous regulatory and quality standards review by maihub Corp. to guarantee functionality, safety and security are made available in maiLink.

    maiLink simply presents the simple AI response output, and the initial anonymized image remains consistently available. The duty of evaluating the AI output, validating the results, and conducting the diagnosis lies with competent medical professionals.

    AI/ML Overview

    N/A

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