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MammoScreen BD

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K243685

by Therapixel

Identifiers

510(k) Number
K243685 FDA 510(k)
FDA Product Code
QIH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MammoScreen BD is a breast imaging device classified as a Digital Breast Tomosynthesis System (UDI Class II). It provides three-dimensional mammographic imaging to enhance the detection and evaluation of breast lesions by capturing multiple low-dose X-ray images from different angles, reconstructing them into cross-sectional slices for improved visualisation of tissue structures.

This device is intended for use in radiology departments within healthcare facilities, offering single-use disposable components where applicable. Supplied sterile and designed for reusable components as specified by the manufacturer, it adheres to MRI safety standards for non-ferromagnetic materials. The system operates with a defined field of view and is authorised under FDA 510K clearance (K243685) and the European Medical Device Directive (MDD).

Frequently asked questions

What types of disposable components are included with the MammoScreen BD, and how do they impact its use in clinical settings?

The MammoScreen BD includes single-use disposable components as part of its design, which helps maintain sterility and reduce cross-contamination between patients. These disposables are intended to simplify workflows in radiology departments by minimizing the need for extensive cleaning and reprocessing of reusable parts, ensuring consistent imaging quality and compliance with infection control protocols.

How does the MammoScreen BD ensure safety for patients who may require MRI scans after their breast imaging?

The MammoScreen BD is designed with non-ferromagnetic materials, adhering to MRI safety standards. This means patients who undergo imaging with this device can safely proceed to MRI scans afterward without risk of interference or injury from magnetic fields, provided the MRI facility follows standard safety protocols for non-ferromagnetic medical devices.

What is the primary purpose of the MammoScreen BD’s three-dimensional imaging capability, and how does it differ from traditional mammography?

The MammoScreen BD’s three-dimensional imaging capability—achieved through low-dose X-ray slices from multiple angles—enhances the detection and evaluation of breast lesions by providing clearer visualization of tissue structures compared to traditional 2D mammography. This reduces overlap of dense tissue and improves the ability to identify abnormalities, particularly in complex cases.

Are there specific storage requirements for the MammoScreen BD, and how should its reusable components be maintained?

While the device specifications do not detail exact storage conditions, the MammoScreen BD’s reusable components should be stored in a clean, dry environment to prevent contamination or damage. The manufacturer’s instructions (not provided here) would outline proper cleaning, disinfection, and maintenance protocols to ensure longevity and performance, including adherence to MRI safety standards for non-ferromagnetic materials.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Therapixel

Sources (2)

  • FDA 510(k) K243685 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026