MammoScreen® (4)
TherapixelMammoScreen® is an AI-based software designed to assist radiologists in detecting and diagnosing lesions that may be indicative of breast cancer from mammography images. It helps improve accuracy and efficiency by highlighting suspicious areas, supporting earlier and more reliable cancer detection.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2024
7 months - 2
FDA Approval
7/3/2025
Other devices from Therapixel
- MammoScreen BD2024 • 510K
- MammoScreen� (3)2024 • 510K
- MammoScreen 2.02021 • 510K
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