510(k) · Cleared
ClearedViz LVO ContaCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viz. Ai, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Oct 21, 2022 as substantially equivalent to DEN170073 (Viz.Al, Inc., 2018) after a 22-day review. Its family tree reaches back 1 generation to 2018. 3 later devices descend from it.
- Decided
- Oct 21, 2022
- Review
- 22 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170073 (2018). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN170073 ContaCTViz.Al, Inc. · 2018
- This deviceK223042 Viz LVO ContaCTViz. Ai, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK251610 qER-CTA (v1.0)Qure.Ai Technologies · 2025
- Descendant · cites it directly · 0 of its ownK241480 JBS-LvoJLK, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231837 Brainomix 360 Triage LVOBrainomix Limited · 2023
Most influential descendants
Showing 3 of 3 · See allView 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) | K223042 | Viz LVO ContaCT | Viz. Ai, Inc. | 2022 | — |
| +1 | K251610 | qER-CTA (v1.0) | Qure.Ai Technologies | 2025 | — |
| +1 | K241480 | JBS-Lvo | JLK, Inc. | 2024 | — |
| +1 | K231837 | Brainomix 360 Triage LVO | Brainomix Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | DEN170073 | ContaCTSummary page 4…Manufacturer Device Name Application No. Viz.ai, Inc. ContaCT DEN170073 Purpose of Special 510(k) Viz LVO is a modification to the predicate device, ContaCT. This Special 510(k) was submitted for c… | 2018 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All QAS devicesQAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QAS
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAS
101in 2025
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 0 |
| 2019 | 5 | 111 | 0 | 0 |
| 2020 | 12 | 112 | 0 | 0 |
| 2021 | 5 | 86 | 0 | 0 |
| 2022 | 15 | 116 | 0 | 0 |
| 2023 | 11 | 98 | 0 | 0 |
| 2024 | 12 | 136 | 0 | 0 |
| 2025 | 15 | 101 | 0 | 0 |
| 2026 | 11 | 104 | 0 | — |
What is it indicated for?
Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image…
Read the full statement (220 words)
Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to
identify and communicate images of specific patients to a specialist, independent of standard of care
workflow.
Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified
clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of
care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification.
Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting, and sends
notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and
recommends review of those images. Images can be previewed through a mobile application. Viz LVO is
intended to analyze terminal ICA and MCA-M1 vessels for LVOs.
Images that are previewed through the mobile application are compressed and are for informational
purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for
viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and
relevant discussion with a treating physician before making care-related decisions or requests. Viz LVO is
limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to
make or confirm diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223042: Viz LVO ContaCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223042
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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