510(k) · Cleared

Cleared

StrokeSENS LVO

K212261510(k) TraditionalCleared Oct 14, 202186-day reviewClass II21 CFR 892.2080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Circle Neurovascular Imaging, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software

Cleared on Oct 14, 2021 as substantially equivalent to DEN170073 (Viz.Al, Inc., 2018) after an 86-day review. Its family tree reaches back 1 generation to 2018.

Decided: Oct 14, 2021
Review: 86 days
Class: Class II
Product code: QAS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN170073 (2018). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backDEN170073 ContaCTViz.Al, Inc. · 2018
This deviceK212261 StrokeSENS LVOCircle Neurovascular Imaging, Inc. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN170073	ContaCT	Viz.Al, Inc.	2018	—
0 (this device)	K212261	StrokeSENS LVO	Circle Neurovascular Imaging, Inc.	2021	—

FIG. 1 — Lineage of K212261, 2018–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QAS device

#1 K203508 BriefCasescore 25.5 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN170073	ContaCT Summary page 5 …Product Code: QAS Regulation Number: 21 CFR 892.2080 III. PREDICATE DEVICE ContaCT, manufactured by Viz.AI (DEN170073) IV. DEVICE DESCRIPTION StrokeSENS LVO is intended to assist hospital networks and trained clinicians in workflow triage…	Viz.Al, Inc.	2018	—

Also cleared against DEN170073: 9 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
9 other devices also cite its predicate DEN170073.

How does its category compare?

All QAS devices

QAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · QAS

15in 2025

2007high 15 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QAS

101in 2025

2007high 136 (2024) · low 86 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QAS

No recall names QAS since 2007.

Adverse event reports per year · QAS

No MAUDE report names QAS since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	3	—	0
2019	5	111	0
2020	12	112	0
2021	5	86	0
2022	15	116	0
2023	11	98	0
2024	12	136	0
2025	15	101	0
2026	11	104	—

What is it indicated for?

StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected LVO…

Read the full statement (221 words)

StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.

Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage / prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K212261 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212261: StrokeSENS LVO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212261

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026