FDA-cleared K251416
UltraSight Guidance
Ultrasight , Ltd.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-12-17
Buyer-fit notes
Genius AI Detection 2.0 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.
FDA and evidence source ledger
Clinical use
Image analysis/processing.
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