StrokeSENS ASPECTS Software Application
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250221 FDA 510(k)
- FDA Product Code
- POK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2060 FDA 510(k)
- Regulation Number
- 892.2060 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What clinical specialty does the StrokeSENS ASPECTS Software Application support, and how does it assist in patient care?
The StrokeSENS ASPECTS Software Application is designed for use in radiology departments, specifically to assist in acute ischemic stroke assessment. It quantifies and analyzes perfusion deficits in brain imaging studies, helping clinicians evaluate treatment eligibility by providing objective data to inform clinical decision-making.
Is this software intended for single-use or repeated use in a clinical setting, and what are its deployment requirements?
The StrokeSENS ASPECTS Software Application is not single-use—it is a digital tool intended for repeated use in radiology departments. It operates on a standalone or networked system, meaning it can be integrated into existing hospital IT infrastructure without requiring physical sterility or disposable components.
How is this software regulated, and what does its classification mean for healthcare providers?
The software is authorized under FDA 510K, MDD, and MDR frameworks, with a Class II designation, indicating it has been deemed substantially equivalent to a predicate device. This classification means it undergoes rigorous review for safety and effectiveness but does not require the same stringent oversight as higher-risk devices (e.g., Class III). Providers can rely on its regulatory clearance for clinical use in acute stroke assessment.
Does this software require any special handling or storage conditions, and is it compatible with specific imaging modalities?
Since the StrokeSENS ASPECTS Software Application is a digital tool, it does not require physical storage conditions like temperature control or sterile packaging. However, it is designed to work with brain imaging studies (e.g., CT or MRI perfusion scans) to analyze perfusion deficits. Compatibility details are not specified in the regulatory data, but it is intended for use with standard radiology systems in healthcare settings.
What regulatory route was followed for this software’s approval, and what does the advisory committee designation mean?
The software was cleared via a traditional FDA 510K pathway, meaning its safety and performance were compared to a legally marketed predicate device. The Radiology (RA) advisory committee reviewed its submission, which is standard for devices in this specialty. This process ensures the software meets established benchmarks for computer-assisted diagnostic tools in stroke assessment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250221 | Class II | Active |
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Manufacturer
- Manufacturer
- Circle Cardiovascular Imaging Inc
- FDA Applicant
- Circle Cardiovascular Imaging, Inc.
Sources (2)
- FDA 510(k) K250221 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026