# K241719: NeuroICH

- Pathway: 510(k) (Traditional)
- Applicant: Neurocareai, Inc.
- Decided: Nov 7, 2024 after 146 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210209: Viz ICH, Viz. Ai, Inc. (2021) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K241719
Methodology: https://510kreport.com/methodology