Saige-Density (2.5.0)
DeepHealth, IncSaige-Density is a software tool that analyzes digital mammography and breast tomosynthesis images to categorize breast density according to the ACR BI-RADS Atlas 5th Edition. It aids radiologists by providing adjunctive information to help assess breast tissue composition, improving the evaluation process, although it is not a diagnostic aid itself.
Intended Use
Saige-Density is a software application intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in assessing breast tissue composition and produces adjunctive information, not intended as a diagnostic aid.
Technology
Saige-Density uses deep learning techniques to process 2D digital mammogram DICOM files (including FFDM and 2D synthetics) to generate a study-level breast density category output. It produces a structured report (SR) and a secondary capture (SC) DICOM object containing the density category, viewable on mammography workstations.
Performance
Verification included software unit, integration, and system testing confirming software met requirements. Validation was via retrospective study with data from different clinical sites than used in training, ensuring broad geographic and racial diversity. Validation data did not overlap with training data, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/29/2024
20 days - 2
FDA Approval
12/19/2024
Other devices from DeepHealth, Inc
- TechLive2025 • 510K
- Saige-Dx (3.1.0)2024 • 510K
- Saige-Dx2024 • 510K
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