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510(k) Data Aggregation

    K Number
    K260087

    Validate with FDA (Live)

    Date Cleared
    2026-03-24

    (71 days)

    Product Code
    Regulation Number
    892.1715
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K173576, K211215, K193334

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

    Senographe Pristina: The Senographe Pristina system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

    SenoBright HD: SenoBright HD is an extension of the existing indication for diagnostic mammography with Senographe Pristina. The SenoBright application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and ultrasound exams to help localize a known or suspected lesion

    Pristina Serena: The Pristina Serena option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA).

    Pristina Serena Bright: The Pristina Serena Bright option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images acquired with Contrast Enhanced Spectral Mammography (CESM) under the same breast compression. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA). CESM-Biopsy application is indicated for patients with suspicious lesions only seen with certainty when imaged with a contrast agent or that do not have a definite correlate on mammography or ultrasound

    Device Description

    Senographe Pristina (Full Field Digital Mammography)

    Senographe Pristina is a full field digital mammography system intended for breast cancer screening and diagnostic mammography. The system acquires two dimensional (2D) digital mammography images and provides on screen image display, archiving, networking, and filming capabilities. It incorporates a large detector enabling imaging of large breasts, adjustable paddles for
    positioning smaller breasts, and system adjustments to support patient positioning during standard mammography examinations.

    SenoBright HD (Contrast Enhanced Spectral Mammography – CESM)

    SenoBright HD is the CESM configuration of the Senographe Pristina platform. CESM acquires paired low-energy (LE) and high-energy (HE) images following intravenous administration of an iodinated contrast agent. From these acquisitions, the system generates recombined iodine-specific images to assist in the assessment of suspicious lesions.

    Pristina Serena (Stereotactic Biopsy – 2D)

    Pristina Serena is a stereotactic biopsy accessory used with the Senographe Pristina imaging platform. The Biopsy Positioner mounts onto the system in place of the Bucky and supports vertical and horizontal biopsy approaches. It includes a needle holder compatible with various needle guides, enabling precise lesion targeting based on 2D angled mammographic views.

    Pristina Serena Bright (CESM Guided Biopsy)

    Pristina Serena Bright is a CESM guided biopsy option used with Pristina Serena. It acquires paired low-energy and high energy images to produce both conventional mammographic images and iodine specific images to guide biopsy for contrast enhancing lesions.

    AI/ML Overview

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