# K222884: Rapid NCCT Stroke

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Mar 2, 2023 after 161 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: 3 generations back to DEN170073 (2018). 3 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200855: CINA, Avicenna.Ai (2020) Summary page 5.

## Most influential descendants
- K232496: Brainomix 360 Triage Stroke (2023), 1 descendant of its own
- K252421: JLK-NCCT (2026), 0 descendants of its own
- K253818: Annalise Enterprise (2026), 0 descendants of its own
- K251983: Brainomix 360 Triage Stroke (2025), 0 descendants of its own
- K250685: Methinks NCCT Stroke (2025), 0 descendants of its own

## Indications for use
Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) NCCT large vessel occlusion (LVO) of the ICA and MCA-M1. Rapid NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) NCCT LVO on the Rapid server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings via PACS, email or mobile device. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Rapid NCCT Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. Rapid NCCT Stroke is for Adults only. Cautions: • All patients should get adequate care for their symptoms including CTA and/or other appropriate care per the standard clinical practice, irrespective of the device output. • The device is not intended to be a rule-out device and for cases that have been processed by the device without notification for “Suspected LVO” should not be viewed as indicating that LVO is excluded. All cases should undergo CTA, per the standard stroke workup. Limitations: • Rapid NCCT Stroke does not replace the need for CTA or MRA in ischemic stroke workup, it provides workflow prioritization and notification only. • Rapid ICH has been shown to reliably identify hemorrhages of ≥ 0.4ml. Contraindications/Exclusions • Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. • Hemorrhagic Transformation, Hematoma • Very thin or no Ventricles

Source page: https://510kreport.com/device/K222884
Methodology: https://510kreport.com/methodology