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510(k) Data Aggregation

    K Number
    K231760
    Device Name
    HP-OCT (HP-OCT)
    Manufacturer
    Cylite Pty Ltd
    Date Cleared
    2024-03-08

    (266 days)

    Product Code
    HJO, MXK, OBO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cylite Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HP-OCT™ instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of the posterior segment of the eye.
    Device Description
    The Cylite Hyperparallel Optical Coherence Tomographer (HP-OCT) is an ophthalmic OCT system, intended to assist ophthalmic professionals in the diagnosis of ophthalmic conditions via non-contact imaging of the posterior segment. OCT imaging is accomplished in the HP-OCT instrument using a micro-lens array to separate the illumination from a super-luminescent diode (SLD) source into an array of parallel beamlets. The beamlet array is then projected simultaneously onto the eye. Each of the individual beamlets is equivalent to a single beam of an SD-OCT (Spectral Domain OCT) system. Each beamlet generates a spectral interferogram, equivalent to a single SD-OCT interferogram, which is processed to produce an individual A-scan. A set of 1008 parallel, SD-OCT type A-scans is thus acquired for each frame of the CMOS sensor, and multiple frames can be acquired to create dense volume images. The HP-OCT instrument is supplied with an exchangeable lens which supports OCT imaging of the posterior segment. The HP-OCT instrument is operated from the Cylite Focus softwarethat runs from a Windows 10 personal computer (PC) supplied by the user. The PC hosts the HP-OCT Capture and Focus Review software and connects to the HP-OCT instrument via a USB 3.0/3.1 cable. From the PC/software, the user employs the PC monitor, keyboard and mouse to interact with the HP-OCT instrument to perform instrument alignment, preview images, capture images, save or load image or patient data, review images, and manage patient data.
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