FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
K Number: K232526
·
Decision Sep 12, 2023
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
297
Applicant Total
87
Review Days
22
Basic Information
- Device Name
- XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
- K Number
- K232526
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon Medical Systems Corporation
- Date Received
- August 21, 2023
- Decision Date
- September 12, 2023
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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