Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
FDA 510(k) K251602 · Canon Medical Systems Corporation
510(k) numberK251602
Submission
- Device name
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
- Applicant
- Canon Medical Systems Corporation
Otawara-Shi, JP - Received
- May 27, 2025
- Decision date
- October 10, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging cleared by the FDA?
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (K251602) received a 510(k) decision of Substantially Equivalent on October 10, 2025, 136 days after the submission was received.
What is the product code of K251602?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.