FDA-cleared K252856
PeekMed web
Peek Health, S.A.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-12-22
FDA-cleared profile
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Image analysis/processing.
Buyer-fit notes
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is best reviewed for CT/CTA teams evaluating ct/cta 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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