XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5— 510(k) K232526
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K232526 for XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5, Substantially Equivalent on 2023-09-12. Applicant: Canon Medical Systems Corporation.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Otawara-Shi, JP
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.