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StrokeSENS LVO

by Circle Neurovascular Imaging, Inc.

510(k) K212261

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212261 Date14 Oct 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QAS
Device Class
Class II
Regulation
21 CFR Part 892.2080
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

StrokeSENS LVO is a radiological computer-assisted triage and notification software. It is an AI-powered medical imaging software and notification tool used to augment acute stroke image analysis.

It supports communication and collaboration across stroke teams and is used by hospital networks and trained professionals. The device has FDA 510(k) clearance under K-number K212261 and is classified as a Class II device in the radiology specialty.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is StrokeSENS LVO used for?

    StrokeSENS LVO is an AI-powered medical imaging software and notification tool used to augment acute stroke image analysis by supporting communication and collaboration across stroke teams in hospital networks.

  • How is StrokeSENS LVO supplied or accessed?

    StrokeSENS LVO is supplied as radiological computer-assisted triage and notification software, designed for use by trained professionals in hospital networks to support acute stroke workflows.

  • Is StrokeSENS LVO a single-use or reusable device?

    StrokeSENS LVO is software and not a physical device subject to single-use or reuse limitations; it is intended for repeated use in clinical settings by authorized personnel.

  • What regulatory clearance does StrokeSENS LVO have?

    StrokeSENS LVO has FDA 510(k) clearance under K-number K212261 and is classified as a Class II device in the radiology specialty.