FDA-cleared K251602
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-10-10
FDA-cleared profile
O-arm O2 Imaging System
Image analysis/processing.
Buyer-fit notes
O-arm O2 Imaging System is best reviewed for Fluoroscopy/Angiography teams evaluating fluoroscopy/angiography workflow 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.
Alternatives
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FDA-cleared K250660
LUMINOS Q.namix T; LUMINOS Q.namix R
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Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-07-14
FDA-cleared K243884
TAVIPILOT
Caranx Medical
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-07-07
FDA-cleared K243446
3DXR
GE Medical Systems SCS
Image analysis/processing.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- N/A
- Decision
- 2025-02-25