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510(k) Data Aggregation

    K Number
    K983401
    Device Name
    FRAMEWAVE WEB
    Manufacturer
    ML STRATEGIES, INC.
    Date Cleared
    1998-12-15

    (78 days)

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

    FRAMEWAVE WEB

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

    The Access Radiology "Framewave Web" Image and Information System is indicated for the display and management of radiologic images and associated information stored and transmitted in both compressed and uncompressed form.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Framewave™ Web" dated December 15, 1998. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding specific acceptance criteria, device performance, details of a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or how ground truth was established for training or testing sets. The letter is a regulatory approval, not a scientific study report.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only confirms the device's regulatory classification and permissibility to market.

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