StrokeSENS ASPECTS Software Application— 510(k) K250221
Substantially EquivalentCircle Cardiovascular Imaging, Inc.
FDA 510(k) clearance K250221 for StrokeSENS ASPECTS Software Application, Substantially Equivalent on 2025-07-01. Applicant: Circle Cardiovascular Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Circle Cardiovascular Imaging, Inc.
- Product code
- Code POK
- Device class
- Class 2
- Regulation
- 21 CFR 892.2060
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calgary, CA
Recent devices under product code POK
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