FDA-cleared K250959
BioticsAI
Bioticsai, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-22
FDA-cleared profile
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Image analysis/processing.
Buyer-fit notes
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program is best reviewed for Ultrasound teams evaluating ultrasound workflow 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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