510(k) · Radiology

StrokeSENS ASPECTS Software Application

by Circle Cardiovascular Imaging Inc.

StrokeSENS ASPECTS Software Application is an AI-enabled medical device from Circle Cardiovascular Imaging Inc. that the U.S. FDA cleared through 510(k) K250221 on July 1, 2025. Its lead review panel is Radiology and its primary product code is POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK250221
Pathway510(k)
Date of final decision
Company (FDA list)Circle Cardiovascular Imaging Inc.
Lead review panelRadiology
Primary product codePOK — Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Applicant (openFDA)Circle Cardiovascular Imaging, Inc.
Applicant locationCalgary, CA
Device classClass 2
Regulation number21 CFR 892.2060
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. StrokeSENS ASPECTS Software Application went through this pathway (K250221).

openFDA lists it as a Class 2 device under 21 CFR 892.2060. Class II devices are moderate risk and are subject to general and special controls.

Product code POK covers 22 devices on the FDA AI list. By decision date, this device is #18 of 22 under that code. Circle Cardiovascular Imaging Inc. has 7 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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