# StrokeSENS ASPECTS Software Application

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/strokesens-aspects-software-application-pok>
- Manufacturer: [Circle Cardiovascular Imaging Inc](https://devicerts.com/manufacturers/circle-cardiovascular-imaging-inc) (Canada, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: POK

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The StrokeSENS ASPECTS Software Application is a Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer, classified under the Radiology specialty. It is designed to assist in the assessment of acute ischemic stroke by quantifying and analyzing perfusion deficits in brain imaging studies, aiding in clinical decision-making for treatment eligibility.

This software is supplied as a digital application, intended for use in radiology departments within healthcare settings. It operates on a standalone or networked system, requiring no physical sterility or single-use considerations. The device is authorized under FDA 510K, MDD, and MDR regulatory frameworks, with a Class II designation. No MRI safety or physical size specifications are noted in the regulatory data.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K250221 · decision 2025-07-01 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active
- **EUDAMED** · CE/MDD · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K250221 [FDA 510(k)]
- FDA product code: POK [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2060 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: StrokeSENS ASPECTS Software Application, Circle Cardiovascular Imaging Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/strokesens-aspects-software-application-pok (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/strokesens-aspects-software-application-pok.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/strokesens-aspects-software-application-pok
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.