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
Volpara Imaging Software
Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis.
Buyer-fit notes
Volpara Imaging Software 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
Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis.
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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