# K200941: Rapid LVO

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Jul 9, 2020 after 92 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.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193087: Rapid ICH, Ischemaview Incorporated (2020) Summary page 4.

## Most influential descendants
- K251151: Rapid CTA 360 (2025), 1 descendant of its own
- K261085: Rapid Vessel Occlusion (Rapid VO) (2026), 0 descendants of its own
- K221248: Rapid LVO (2022), 0 descendants of its own

## Indications for use
Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images. Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO 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 LVO findings. Notifications include compressed preview images, that are meant for informational purposes only and 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 LVO 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. Contraindications/Exclusions/Cautions: • Rapid LVO is one input to physician diagnosis for patients undergoing screening for acute ischemic stroke. • Excessive patient motion may lead to artifacts that make the scan technically inadequate. • Identification of suspected findings is not for diagnostic use beyond notification. Images that are previewed through email and 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.

Source page: https://510kreport.com/device/K200941
Methodology: https://510kreport.com/methodology