FDA-authorized DEN240047
Allix5
Clairity, Inc.
Computer-aided detection/diagnosis
- Modality
- Modality not specified in FDA list
- Anatomy
- N/A
- Decision
- 2025-05-30
FDA-approved profile
Imagio Breast Imaging System
Computer-aided detection/diagnosis
Buyer-fit notes
Imagio Breast Imaging System is best reviewed for Modality not specified in FDA list 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.
FDA and evidence source ledger
Clinical use
Computer-aided detection/diagnosis
Alternatives
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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-authorized DEN230023
Rho
16 Bit Inc
Computer-aided detection/diagnosis
- Modality
- Modality not specified in FDA list
- Anatomy
- N/A
- Decision
- 2024-04-09
FDA-cleared K161959
ClearView cCAD
ClearView Diagnostics Inc.
earView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images.
- Modality
- Ultrasound
- Anatomy
- Breast
- Decision
- 2016-12-28