Digital Breast Tomosynthesis option for Senographe Essential


Product Overview

Digital Breast Tomosynthesis option for Senographe Essential
SenoClaire - LLH1


Device Description

A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 50.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 10.00
  • Handling Environment Temperature - Degrees Celsius
    • 70.00
    • -20.00
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 50.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 70.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OTE

    Device Name: Digital Breast Tomosynthesis

    Device Class: 3

    Physical State: Hardware and software for acquiring and reconstructing digital projection images. May incorporate similar equipment as full-field digital mammography systems.

    Definition: To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.

    Submission Type ID: 2

    Review Panel: RA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Projection images are acquired over the stationary breast and reconstructed to produce cross-sectional ¿slices¿ through the breast.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Breast

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00840682100045

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos