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-approved profile
Computer-aided detection/diagnosis
MAMMOMAT B.brilliant with Tomosynthesis Option 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 or teams requiring confirmed deployment details before shortlist review.
Computer-aided detection/diagnosis
Alternatives
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Image analysis/processing for Breast using Mammography/DBT.
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Visage Imaging GmbH
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