Cleared Traditional

StrokeSENS ASPECTS Software Application

K250221 · Circle Cardiovascular Imaging, Inc. · Radiology
Jul 2025
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K250221 is an FDA 510(k) clearance for the StrokeSENS ASPECTS Software Application, a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code POK), submitted by Circle Cardiovascular Imaging, Inc. (Calgary, CA). The FDA issued a Cleared decision on July 1, 2025, 158 days after receiving the submission on January 24, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2060.

Submission Details

510(k) Number K250221 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2025
Decision Date July 01, 2025
Days to Decision 158 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code POK — Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images