FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
K Number: K251602
·
Decision Oct 10, 2025
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
97
Review Days
136
Basic Information
- Device Name
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
- K Number
- K251602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon Medical Systems Corporation
- Date Received
- May 27, 2025
- Decision Date
- October 10, 2025
- Product Code
- OWB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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