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510(k) Data Aggregation

    K Number
    K984030
    Device Name
    VIPERSOFT
    Manufacturer
    INTEGRA MEDICAL
    Date Cleared
    1999-02-10

    (90 days)

    Product Code
    EHD,LMB,LMD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The software, Vipersoft, for extraoral X-ray units is used to process digital images from extraoral X-ray units in order to enable a dentist to diagnose the dental state of the teeth of a patient.

    Device Description

    Software for extraoral X-ray units

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an Indications for Use statement for the "Vipersoft™ (Software for Extraoral X-ray Units)".

    This document does not contain any information regarding:

    • Acceptance criteria or reported device performance
    • Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance studies) for Vipersoft™.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or any of the study details you've asked for, as this information is not present in the provided text.

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