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510(k) Data Aggregation

    K Number
    K034054
    Device Name
    PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2004-02-20

    (52 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100

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

    Interface between treatment planning system and the MED-TEC Pro Series Couch; or: Software for MED-TEC Pro Series Couch (6 Degree Axis Couch) .

    Device Description

    Not Found

    AI/ML Overview

    This FDA 510(k) letter for the "Pro Series Couch Software" by MED-TEC, Inc. (K034054) is a regulatory clearance document. It does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

    The letter explicitly states that the device is determined to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA has not conducted a de novo review of performance or efficacy in the way that would typically involve acceptance criteria and detailed study results. Instead, the focus is on whether the new device is as safe and effective as devices already on the market.

    Therefore, I cannot provide answers to the requested points based on the provided document. The document pertains to regulatory clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.

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