MammoScreen (3)
FDA 510(k)Class II (US FDA 510(k))
by Therapixel
Identifiers
- 510(k) Number
- K240301 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 is a radiological computer-assisted detection/diagnosis software for lesions suspicious for cancer. It is intended for use as a concurrent reading aid for physicians interpreting screening mammograms to identify regions suspicious for breast cancer and assess their likelihood of malignancy. The device output includes marks placed on abnormal regions of the mammogram and likelihood of malignancy scores.
MammoScreen (3) is supplied as a software medical device and is not specified as single-use or reusable. The device is FDA-cleared with product code QDQ and is classified as a class II medical device. It is designed for use in radiology departments for mammography and digital breast tomosynthesis (DBT) interpretation.
Frequently asked questions
What is MammoScreen (3) used for?
MammoScreen (3) is a radiological computer-assisted detection/diagnosis software designed to help physicians identify regions suspicious for breast cancer and assess their likelihood of malignancy when interpreting screening mammograms and digital breast tomosynthesis (DBT).
How is MammoScreen (3) supplied?
MammoScreen (3) is supplied as a software medical device. The device is not specified as single-use or reusable, and it is designed for use in radiology departments for mammography and digital breast tomosynthesis interpretation.
What is the regulatory status of MammoScreen (3)?
MammoScreen (3) is FDA-cleared with product code QDQ and is classified as a class II medical device. It received FDA clearance through the traditional pathway with decision code SESE on August 1, 2024.
What does the output of MammoScreen (3) include?
The device output includes marks placed on abnormal regions of the mammogram and likelihood of malignancy scores, serving as a concurrent reading aid for physicians during mammogram interpretation.
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: MammoScreen® - Therapixel, About - MammoScreen®, MammoScreen® (3) | Therapixel radiology AI profile, Therapixel: MammoScreen® (3) (FDA-cleared AI medical device)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240301 | Class II | Active |
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Manufacturer
- Manufacturer
- Therapixel
Sources (1)
- FDA 510(k) K240301 24 fields · synced Sep 22, 2026