510(k) · Cleared
ClearedNeuroICH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurocareai, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Nov 7, 2024 as substantially equivalent to K210209 (Viz. Ai, Inc., 2021) after a 146-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Nov 7, 2024
- Review
- 146 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170073 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K210209 | Viz ICHSummary page 5…: QAS Predicate Device: Manufacturer Device Name Application Number Viz.ai, Inc. Viz ICH K210209 510(k) Summary Page 1 of 8 NEUROCAREAI I… | 2021 |
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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K210209.
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. 2024, 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?
NeuroICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of suspected ICH patients to a specialist, independent of standard of care workflow. The device uses an artificial intelligence algorithm to analyze non-contrast CT images of the head acquired in the acute setting for findings suggestive of intracranial hemorrhage (ICH) in parallel to the ongoing standard of care…
Read the full statement (180 words)
NeuroICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of suspected ICH patients to a specialist, independent of standard of care workflow.
The device uses an artificial intelligence algorithm to analyze non-contrast CT images of the head acquired in the acute setting for findings suggestive of intracranial hemorrhage (ICH) in parallel to the ongoing standard of care image interpretation and notify an appropriate clinician of these findings. Notifications include non-diagnostic preview images that are meant for informational purposes only. The device does not alter or remove the original medical image and is not intended to be used as a diagnostic device. Images can be previewed through a mobile application.
Notified clinicians are responsible for viewing high quality images on a diagnostic viewer per the standard of care and engaging in appropriate patient evaluation in conjunction with other patient information before making care-related decisions. NeuroICH 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/K241719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241719: NeuroICH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241719
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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