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
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
Image analysis/processing.
Buyer-fit notes
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) 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.
FDA and evidence source ledger
Clinical use
Image analysis/processing.
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- Modality
- Fluoroscopy/Angiography
- Anatomy
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- Decision
- 2025-02-25