FDA-cleared K251416
UltraSight Guidance
Ultrasight , Ltd.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-12-17
Buyer-fit notes
Radiomics App v1.0 is best reviewed for Mammography/DBT 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
Image analysis/processing.
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