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510(k) Data Aggregation

    K Number
    K973400
    Device Name
    MAMMOTEST ADAPTER DRIVER
    Manufacturer
    FISCHER IMAGING CORP.
    Date Cleared
    1997-11-10

    (62 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAMMOTEST ADAPTER DRIVER

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

    Adaptation for use on the Mammotest® System tables when the clinician wishes to use the Auto Suture ABBI* System for large core biopsy.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Mammotest® Adapter Driver." It acknowledges that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related information requested in the prompt.

    The letter is a regulatory approval, not a technical report or a study summary. It confirms the device's clearance for marketing based on substantial equivalence, but it does not detail the technical performance studies that might have been submitted to support that claim.

    Therefore, I cannot provide the requested table and study information based solely on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the full 510(k) submission, which would contain the technical data and study details.

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