FDA-cleared K222176
BoneView
Gleamer
Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Bone
- Decision
- 2023-03-02
FDA-cleared profile
FractureDetect (FX)
Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.
Buyer-fit notes
FractureDetect (FX) is best reviewed for PET/SPECT/Nuclear Medicine 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 PET/SPECT/Nuclear Medicine.
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