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510(k) Data Aggregation

    K Number
    K251848

    Validate with FDA (Live)

    Date Cleared
    2026-03-13

    (270 days)

    Product Code
    Regulation Number
    886.1850
    Age Range
    22 - 74
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pentacam® Cornea OCT is a multifunction ophthalmic imaging device designed to acquire images of the anterior segment using Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and OCT.

    Scheimpflug imaging provides anterior segment visualization and quantitative anterior segment measurements.

    The OCT component of the system uses broadband Multi-SLD and is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium.

    The Pentacam® Cornea OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye.

    Device Description

    The Pentacam® Cornea OCT combines functions of the Scheimpflug technology of the cleared Oculus GmbH Pentacam® AXL Wave device (K201724), which is used for evaluating anterior segment of the eye, with the additional functionality of optical coherence tomography (OCT). The device is intended for using both systems together (Scheimpflug imagining and OCT) by two parallel scans for evaluating anterior segment (cornea, pupil, anterior chamber and lens of the eye) of the eye by Scheimpflug and in vivo imaging, cross-sectional and three-dimensional imaging, and measurement of corneal epithelium.

    While rotating around the eye, the Pentacam® Cornea OCT captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. Scheimpflug images are captured within two seconds.

    Up to 138,000 (optional 276,000) genuine height values are measured and analyzed from the Scheimpflug images. The Scheimpflug images are the basis for the height data which are used to calculate a mathematical 3D model of the anterior eye segment. At same time any eye movements are recorded and taken into account. A quality specification (QS) indicates the quality of the measurement taken.

    The mathematical 3D model, corrected for eye movements, provides the basis for all subsequent analysis.

    Spectral domain OCT technology scans in parallel with the digital CMOS camera with slit lamp illumination (Scheimpflug). OCT uses broadband Multi-SLD scan with wavelength between 780-1000nm. The OCT functionality is an addition to the prior cleared Oculus Pentacam® AXL Wave device (K201724).

    The OCT system creates images (tomograms) simultaneously with the Scheimpflug system while rotating around the eye.

    Three-dimensional images are obtained by scanning laterally over the sample through varying axes.

    The Pentacam® Cornea OCT is specifically designed for use in scanning the corneal epithelium of the human eye. The OCT component of the system is not intended for retinal imaging or analyses.

    The cornea OCT scans will be in 25 sections / sectional planes, similar to the Scheimpflug sections produced from the Scheimpflug camera and will provide an epithelial thickness map which will provide tissue thickness information in different sections.

    The OCT system operates in conjunction with the Scheimpflug system, capturing images as it rotates around the eye and measures light backscattered from tissue structures.

    AI/ML Overview

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