Skip to content

StrokeSENS ASPECTS Software Application

by Circle Cardiovascular Imaging Inc

510(k) K250221

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250221↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250221 Date1 Jul 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250221 decided 1 Jul 2025 Active
  • EUDAMED Active· +1 more in the status table

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
POK
FDA applicant
Circle Cardiovascular Imaging, Inc.
Device class
Class II
Regulation
21 CFR Part 892.2060
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K250221

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250221
UDI-DISize and differences
StrokeSENS LVO v2.x
Circle Cardiovascular Imaging
v2.x00882916001025 —On the market

Similar devices

Other devices filed under FDA product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Other devices from Circle Cardiovascular Imaging Inc

See all devices from Circle Cardiovascular Imaging Inc →