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510(k) Data Aggregation

    K Number
    K991578
    Device Name
    SMARTSPOT 2000
    Manufacturer
    CMT MEDICAL TECHNOLOGIES, LTD.
    Date Cleared
    1999-06-03

    (28 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SMARTSPOT 2000

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

    The SmartSpot 2000 is indicated for the acquisition, storage, processing (enhancement), printing and display of fluoroscopic and digital x-ray spot images.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the SmartSpot 2000 Image Processing System. This document does not contain information about acceptance criteria, study details, or performance metrics for the device.

    Therefore, I cannot provide the requested information. The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices, allowing its marketing. It does not elaborate on the specific studies or data that led to this determination, nor does it define acceptance criteria for the device's performance.

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