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510(k) Data Aggregation

    K Number
    K973090
    Device Name
    MEDSTATION
    Manufacturer
    Date Cleared
    1997-10-28

    (71 days)

    Product Code
    Regulation Number
    892.2020
    Reference & Predicate Devices
    N/A
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MedStation® PACS is a system designed to acquire, store, display and print medical images from the following diagnostic devices: Computed Tomography (CT), Magnetic Resonance Imagers (MRI), Computed Radiography (CR), Direct Radiography (DR), Ultrasound and X-ray Films.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification acceptance letter for a Picture Archiving and Communications Systems (PACS) device, K973090, dated October 28, 1997. It describes the device's indications for use and states that it has been found substantially equivalent to predicate devices. However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document only states:

    • Device Name: MedStation® PACS
    • Indications for Use: MedStation® PACS is a system designed to acquire, store, display and print medical images from the following diagnostic devices: Computed Tomography (CT), Magnetic Resonance Imagers (MRI), Computed Radiography (CR), Direct Radiography (DR), Ultrasound and X-ray Films.
    • Regulatory Class: Unclassified
    • Product Code: 90 LMD

    Therefore, I cannot provide the requested information in a table or answer the specific questions about studies, sample sizes, ground truth, or expert qualifications, as this data is not present in the provided text. This type of information would typically be found in a separate 510(k) summary or a detailed clinical/technical report, not in the acceptance letter itself.

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