FDA-cleared K241593
BoneMetrics (US)
Gleamer SAS
Image analysis/processing for Bone using Ultrasound.
- Modality
- Ultrasound
- Anatomy
- Bone
- Decision
- 2025-02-05
FDA-cleared profile
SpineUs System
Image analysis/processing for Spine using Ultrasound.
Buyer-fit notes
SpineUs System is best reviewed for Ultrasound Spine teams evaluating msk and bone tools with FDA source traceability.
Not ideal for buyers who need public price benchmarks before vendor contact or teams requiring confirmed deployment details before shortlist review.
FDA and evidence source ledger
Clinical use
Image analysis/processing for Spine using Ultrasound.
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