510(k) K250221— StrokeSENS ASPECTS Software Application

Substantially Equivalent

Circle Cardiovascular Imaging, Inc.

Clearance details

Applicant: Circle Cardiovascular Imaging, Inc.
Product code: Code POK
Advisory panel: Radiology
Date received: 2025-01-24
Decision date: 2025-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, CA

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