XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
FDA 510(k) K232526 · Canon Medical Systems Corporation
510(k) numberK232526
Submission
- Device name
- XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
- Applicant
- Canon Medical Systems Corporation
Otawara-Shi, JP - Received
- August 21, 2023
- Decision date
- September 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…JAK · Traditional | 09/26/2025SE |
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Questions and answers
When was XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 cleared by the FDA?
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (K232526) received a 510(k) decision of Substantially Equivalent on September 12, 2023, 22 days after the submission was received.
What is the product code of K232526?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.