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510(k) Data Aggregation

    K Number
    K062021
    Device Name
    KOWA VX-10I
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2006-11-01

    (107 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KOWA VX-10I

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

    KOWA VX -10i is intended for taking pictures of fundus images with mydriatic or without mydriatic.

    Device Description

    KOWA VX-10i Fundus Camera

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the Kowa VX-10i Fundus Camera. It confirms that the device is substantially equivalent to a legally marketed predicate device. This document does not contain information regarding:

    • Acceptance criteria or reported device performance in a table format.
    • Details of a study proving the device meets acceptance criteria.
    • Sample sizes for test sets or training sets.
    • Data provenance.
    • Number or qualifications of experts used for ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth for the training set was established.

    The letter's purpose is to grant market clearance based on substantial equivalence, not to present detailed performance study results.

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