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510(k) Data Aggregation

    K Number
    K012238
    Device Name
    DOSERIGHT
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
    Date Cleared
    2001-10-01

    (76 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K991278,K000819,K982631,K964746
    Why did this record match?
    Reference Devices :

    K991278, K000819, K982631

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

    DoseRight is intended to be used for automatic dose regulation during CT scanning for the purpose of obtaining the desired image quality at the lowest possible dose.

    DoseRight is a software option to the CT Vision family of CT systems. These systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles. They includes signal analysis and display equipment, patient and equipment supports, component parts and accessories which are used in combination with signal and image processing software to facilitate the relative localization of analomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. They are used for the display, storage and analysis of digital diagnostic CT images. They are intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment.

    Device Description

    DoseRight is a software option to the Philips CT Vision product family of computed tomography systems. The CT Vision products are whole body scanners. The CT Vision product family is comprised of the following systems. Each product has been cleared for commercial distribution via the referenced 510(k) submission.

    • · Philips CT Secura (previously named Tomoscan AV-NT, ref: K991278)
    • · Philips CT Secura MV (ref: K000819)
    • · Philips CT Aura (previously named Tomoscan CS, ref: K982631)

    DoseRight is used to enable automatic dose regulation during scanning for the purpose of obtaining the desired image quality at the lowest possible dose. Using DoseRight, the dose required to attain a pre-determined image quality is calculated from the scanogram (scanned projection radiograph) of the patient and resultant scan parameters are then recommended to the user for the scan protocol. The user performs the scanogram in the normal way. At the comletion of the scanogram, and with DoseRight enabled, a mAs/KV combination is displayed to the user, which is the recommended combination to use in the scan protocol to achieve a pra-determined user defined image quality relative to patient diameter. However, if the user so chooses, this recommendation can be ignored and the user can proceed with the standard protocol.

    AI/ML Overview

    The provided document is a 510(k) summary for a device called "DoseRight," a software option for Philips CT Vision systems. It describes the intended use and substantial equivalence to a predicate device but does not contain information about acceptance criteria, specific performance metrics, or details of a study to prove the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and equivalence to an existing device rather than a detailed performance study.

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