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510(k) Data Aggregation

    K Number
    K253111

    Validate with FDA (Live)

    Device Name
    Aeka Imaging
    Date Cleared
    2026-03-13

    (170 days)

    Product Code
    Regulation Number
    892.2050
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Aeka Imaging is a clinical software application that provides a web-based interface for image acquisition and image management in the field of Dentistry and operated by dental professionals who are responsible for providing dental care.
    Aeka Imaging receives patient's dental images from various dental acquisition devices (for eg. radiographic devices, digital image/video capture devices, generic devices such as scanners). Also, the previously acquired images or volumes can be selected for upload directly from the user's computer.
    The software is intended to acquire, display, process edit (rotate, flip, resize, change brightness/contrast/gamma), annotate, review, store, print and distribute patient images using standard PC hardware.

    Device Description

    Aeka Imaging is a clinical software application designed to provide a web-based interface for image acquisition and management in the field of dentistry. Operated by dental professionals responsible for delivering dental care, it supports receiving images and data from digital x-ray sensors, radiographic devices, digital video capture devices, and generic imaging devices such as phosphor plate scanners via Twain integration or Direct integration. Users can also upload previously acquired images directly from their computers. The software allows for acquiring, displaying, processing, editing (e.g., rotating, flipping, resizing, adjusting brightness/contrast), annotating, reviewing, storing, printing, and distributing patient images using standard PC hardware.

    Aeka Imaging has 5 interfaces designed for optimal functionality, which is:

    1. Home Page
    2. Patient Overview
    3. Settings Page
    4. Layouts Page
    5. Acquisition page

    Aeka hub should be installed in all image acquiring workstations. This hub is for facilitating image acquisitions and it is also mandatory to have the device drivers of the Imaging devices installed in these systems as a prerequisite.

    Aeka Imaging also provides a tool for measuring the distance between two endpoints in an image, the value for this measurement tool primarily depends on the value configured by the user. The user set this initial value on the Calibrate option that they have in the Image Editor screen, hence Aeka doesn't auto calculate a measurement.

    Aeka Imaging has supports image acquisition with the below image types:-

    1. X-Ray Images
    2. IO Camera
    3. Panoramic Images

    And Aeka imaging has two types of integration

    1. Twain integration – Aeka supports any Imaging device that has a twain driver.
    2. Direct Integration – Aeka Imaging has 23 direct integration and the list includes Apixia, Athlos, Dental Focus PS-2, e2v, EzSensor, FireCR Dental, Flatbed Scanner, Gendex Scanners, Gendex Sensors, Hamamatsu, iCRco, iRay, Jazz, Nical, Optime, Planmeca IO, Progeny, Rayence, ScanX, ScanX Pro, Sopix, Vidar, VistaRay. This means for all these imaging devices Aeka has Software Development Kit which allows to have a much seamless integration than a conventional twain integration.

    Aeka Imaging integrates with other Practice Management Softwares, enabling users to access Aeka Imaging directly from the PMS. When navigating to Aeka Imaging from the PMS, the patient's context is automatically loaded, with the details transferred from the PMS. The patient information in Aeka Imaging is sourced from the PMS, hence these data solely depend on the PMS data.

    AI/ML Overview

    N/A

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