FDA-cleared K250959
BioticsAI
Bioticsai, Inc.
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-22
FDA-cleared profile
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Image analysis/processing.
Buyer-fit notes
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 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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