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510(k) Data Aggregation

    K Number
    K052076
    Device Name
    DAR-8000I
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Date Cleared
    2005-09-02

    (32 days)

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

    DAR-8000I

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

    This device is intended to be used for radiography in the hospital with X-ray devices.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device named DAR 8000i. This document does not contain information regarding:

    • Acceptance criteria for device performance
    • Details of a study proving the device meets acceptance criteria (including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

    This letter primarily focuses on the FDA's "substantial equivalence" determination, regulatory classifications, and general compliance requirements, rather than a detailed performance study.

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