FDA-cleared K242652
Lunit INSIGHT DBT v1.1
Lunit Inc.
Image analysis/processing for Breast using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2024-10-04
FDA-cleared profile
Visage Breast Density
Image analysis/processing for Breast using Mammography/DBT.
Buyer-fit notes
Visage Breast Density is best reviewed for Mammography/DBT Breast teams evaluating breast imaging tools with FDA source traceability.
Not ideal for buyers who need public price benchmarks before vendor contact.
FDA and evidence source ledger
Clinical use
Image analysis/processing for Breast using Mammography/DBT.
Alternatives
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FDA-approved P140011/S008
MAMMOMAT B.brilliant with Tomosynthesis Option
SIEMENS MEDICAL SOLUTIONS USA, INC.
Computer-aided detection/diagnosis
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2024-09-23
FDA-cleared K231470
Lunit INSIGHT DBT
Lunit Inc.
Image analysis/processing for Breast using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2023-11-06
FDA-cleared K211431
breastscape v1.0
Olea Medical
Image analysis/processing for Breast using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2021-08-02