# StrokeSENS

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

- Canonical page: <https://devicerts.com/devices/strokesens-v2-x>
- Manufacturer: [Circle Cardiovascular Imaging Inc](https://devicerts.com/manufacturers/circle-cardiovascular-imaging) (Canada)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: QAS, POK
- EMDN: Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
- GMDN: CT system application software (40867)

## Registrations and authorizations

- **GUDID** · FDA 510(k) · United States · K250221 · decision 2025-07-01 · decision SESE · status: Active · from GUDID
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 882916SSX6N · UDI-DI 00882916001025 · registered 2025-02-20 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00882916001025 · listed 2025-02-05 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K212261 · decision 2021-10-14 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: StrokeSENS [EUDAMED]; StrokeSENS LVO [FDA GUDID (AccessGUDID)]
- Generic name: CT system application software [FDA GUDID (AccessGUDID)]
- Model / reference: v2.x [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00882916001025 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 882916SSX6N [EUDAMED]
- Direct marketing DI: 00882916001025 [EUDAMED]
- 510(k) Number: K212261 [FDA GUDID (AccessGUDID)]; K250221 [FDA GUDID (AccessGUDID)]
- FDA product code: QAS [FDA GUDID (AccessGUDID)]; POK [FDA GUDID (AccessGUDID)]
- EMDN code: Z11030682 [EUDAMED]
- GMDN term: CT system application software (40867) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.2080 [FDA GUDID (AccessGUDID)]; 892.2060 [FDA GUDID (AccessGUDID)]
- Special device type: Software [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Spain [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: StrokeSENS, Circle Cardiovascular Imaging Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/strokesens-v2-x (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/strokesens-v2-x.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-v2-x
- 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.