Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)— 510(k) K253584
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K253584 for Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension), Substantially Equivalent on 2026-03-10. Applicant: Canon Medical Systems Corporation. Device class: 2.
Summary
Canon Medical Systems' record is for the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension). It's filed under OWB, interventional fluoroscopic x-ray systems, and the record doesn't describe it beyond that name and code name.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Canon Medical Systems filed from Otawara-Shi, Japan. Review took 113 calendar days (November 17, 2025 to March 10, 2026).
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
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Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.