FDA-cleared K253825
Saige-Dx
DeepHealth, Inc.
Authorized purpose: Concurrent detection and characterization support for screening DBT mammography
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2026-06-15
Vendor
DeepHealth, Inc.
9 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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FDA-cleared K254131
BAC
DeepHealth, Inc.
Authorized purpose: BAC processes screening FFDM and DBT mammograms to detect the presence or absence of breast arterial calcifications at study and breast level and localize detected calcifications for qualified interpreting-physician review.
- Modality
- Mammography/DBT
- Anatomy
- Breast; breast arterial calcifications
- Decision
- 2026-05-21
FDA-cleared K251873
Saige-Dx
DeepHealth, Inc.
Authorized purpose: Saige-Dx analyzes screening DBT stacks and associated full-field digital or synthetic 2D mammograms, assigning finding and case suspicion levels to support qualified interpreting physicians; it does not replace their review or clinical judgment.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2025-08-11
FDA-cleared K243688
Saige-Dx (3.1.0)
DeepHealth, Inc.
Authorized purpose: Concurrent reading aid for qualified interpreting physicians on screening DBT mammograms to identify soft-tissue lesions and calcifications that may indicate cancer and assign finding- and case-level suspicion.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2024-12-19
FDA-cleared K243705
Saige-Density (2.5.0)
DeepHealth, Inc
Authorized purpose: Adjunctive assignment of a BI-RADS 5th Edition breast-density category for interpreting-physician review of mammography.
- Modality
- Mammography/DBT
- Anatomy
- Breast tissue composition
- Decision
- 2024-12-19
FDA-cleared K241747
Saige-Dx
DeepHealth, Inc
Authorized purpose: Concurrent reading aid for interpreting physicians on screening DBT mammograms to detect and characterize soft-tissue lesions and calcifications that may indicate cancer.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2024-11-18
FDA-cleared K222275
Saige-Density
DeepHealth, Inc.
Authorized purpose: Provides an adjunctive BI-RADS 5th Edition breast-density category to aid assessment of breast tissue composition; it is not a diagnostic aid.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2022-12-16
FDA-cleared K220105
Saige-Dx
DeepHealth, Inc.
Concurrent-reading software for screening DBT mammography that highlights suspected soft-tissue lesions and calcifications for physician review.
- Modality
- Mammography/DBT
- Anatomy
- Breast; screening DBT findings and calcifications
- Decision
- 2022-05-12
FDA-cleared K203517
Saige-Q
DeepHealth, Inc.
Authorized purpose: Provides passive worklist prioritization for compatible FFDM and DBT screening mammograms.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2021-04-16