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510(k) Data Aggregation

    K Number
    K062360
    Device Name
    BRANSIST SAFIRE
    Manufacturer
    SHIMADZU CORP.
    Date Cleared
    2006-10-05

    (52 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BRANSIST SAFIRE

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

    This device is an angiographic X-ray system, as described in 21 CFR 892.1600. This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positin ing device and other devices.

    Device Description

    This device is an angiographic X-ray system, as described in 21 CFR 892.1600.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the BRANSIST Safire angiographic X-ray system. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    The letter primarily addresses the device's substantial equivalence to predicate devices, its regulatory classification, and general marketing requirements. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth information.

    Therefore, I cannot provide the requested information from the provided text.

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