K232526
- 510(k) number
- K232526
- Device name
- XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- JAA — System, X-Ray, Fluoroscopic, Image-Intensified
- Decision date
- 2023-09-12
- Date received
- 2023-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232526.pdf
Official FDA record: K232526
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.