# K261085: Rapid Vessel Occlusion (Rapid VO)

- Pathway: 510(k) (Traditional)
- Applicant: iSchemaview
- Decided: Jul 13, 2026 after 103 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: 5 generations back to DEN170073 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251151: Rapid CTA 360, Ischemaview (2025) Summary page 5.

## Indications for use
Rapid VO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion findings in head CTA images including the ICA, MCA (M1-M2), and Basilar vascular segments. Rapid VO uses an Al software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected occlusion findings. Notifications include compressed preview images. These 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 is not intended to be used as a diagnostic device. The results of Rapid VO 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 responsible for viewing full images per the standard of care. Rapid VO is for use on Adults.

Source page: https://510kreport.com/device/K261085
Methodology: https://510kreport.com/methodology