K250221
- 510(k) number
- K250221
- Device name
- StrokeSENS ASPECTS Software Application
- Applicant
- Circle Cardiovascular Imaging, Inc. CA
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2025-07-01
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250221.pdf
Official FDA record: K250221
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.