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
breastscape v1.0
Image analysis/processing for Breast using Mammography/DBT.
Buyer-fit notes
breastscape v1.0 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 K201411
Visage Breast Density
Visage Imaging GmbH
Image analysis/processing for Breast using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2021-01-29