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510(k) Data Aggregation

    K Number
    K991815
    Device Name
    EXPLORER 3D
    Manufacturer
    OUR SCIENTIFIC INTL., INC.
    Date Cleared
    1999-08-13

    (78 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K970464
    Why did this record match?
    Device Name :

    EXPLORER 3D

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

    The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.

    The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) summary does not contain the specific information required to answer your request about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    The document is a clearance letter for a device called "Explorer 3D Stereotactic Irradiation Software" (K991815) and an "Indications For Use" statement. It primarily focuses on the substantial equivalence determination to a predicate device (pReference TPS, K970464) and the regulatory classification.

    To answer your questions, I would need a more detailed study report or a different section of the 510(k) submission that specifically addresses the performance testing and validation of the device.

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