MammoScreen 2.0
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Therapixel
Identifiers
- 510(k) Number
- K211541 FDA 510(k)
- FDA Product Code
- QDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2090 FDA 510(k)
- Regulation Number
- 892.2090 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
MammoScreen 2.0 is a Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer, designed to assist radiologists in the analysis of mammographic images. It employs AI-based algorithms to detect and evaluate suspicious lesions in both 2D and 3D mammograms, enhancing diagnostic accuracy and workflow efficiency.
This software is supplied as a digital solution, intended for use in radiology departments within healthcare facilities. It operates as a standalone application, requiring no physical sterilisation or single-use considerations, and is compatible with standard MRI-safe environments. The device is authorised under FDA 510K and MDD, with a classification of Class II. Multiple registration numbers (e.g., 3023522713) correspond to its various software versions and configurations.
Frequently asked questions
How does MammoScreen 2.0 assist radiologists in their daily workflow and what types of mammographic images does it analyze?
MammoScreen 2.0 is an AI-powered software tool designed to help radiologists detect and evaluate suspicious lesions in mammographic images, improving diagnostic accuracy. It analyzes both 2D and 3D mammograms, flagging potential areas of concern for further review. By automating parts of the analysis process, it streamlines workflows and reduces the risk of missed lesions, making it particularly useful in busy radiology departments.
Is MammoScreen 2.0 a physical device that requires sterilization, or is it a digital solution with different deployment requirements?
MammoScreen 2.0 is a fully digital software solution and does not require physical sterilization or single-use considerations. Since it operates as a standalone application within radiology departments, it simply needs to be installed on compatible systems—no physical handling or sterilization protocols apply. This makes it a convenient, low-maintenance addition to existing imaging workflows.
What regulatory pathways has MammoScreen 2.0 followed, and how does this affect its use in clinical settings?
MammoScreen 2.0 has been authorized through FDA 510K clearance and MDD (Medical Device Directive) compliance, classifying it as a Class II device. This means it has undergone rigorous review by regulatory bodies to ensure safety and effectiveness. Clinically, this authorization confirms its suitability for assisting radiologists in detecting suspicious lesions in mammograms, though final diagnostic decisions remain with the interpreting physician.
Are there multiple versions of MammoScreen 2.0, and if so, how do I determine which registration number applies to my specific configuration?
Yes, MammoScreen 2.0 includes multiple software versions and configurations, each with its own registration number (e.g., 3023522713, 3018733944, etc.). These variations correspond to different updates or adaptations of the software. To identify the correct registration number for your setup, consult the installation documentation or your IT/radiology department’s records, as the specific version depends on the system’s configuration and the updates applied during deployment.
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. Sources consulted: A new version of MammoScreen® 2D & 3D - Therapixel, MammoScreen 2.0 | Therapixel radiology AI profile, Clinical - MammoScreen®
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211541 | Class II | Active |
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Manufacturer
- Manufacturer
- Therapixel
Sources (2)
- FDA 510(k) K211541 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026