FDA-cleared K251747
VEA Align; spineEOS
EOS imaging
Image analysis/processing for Spine using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Spine
- Decision
- 2025-08-15
FDA-cleared profile
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Image analysis/processing for Bone using X-ray/Radiography.
Buyer-fit notes
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is best reviewed for X-ray/Radiography Bone teams evaluating msk and bone 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 for Bone using X-ray/Radiography.
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- 2022-10-18