# K241480: JBS-Lvo

- Pathway: 510(k) (Traditional)
- Applicant: JLK, Inc.
- Decided: Sep 27, 2024 after 126 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: 2 generations back to DEN170073 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223042: Viz LVO ContaCT, Viz. Ai, Inc. (2022) Summary page 5.

## Indications for use
JBS-LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. JBS-LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected positive findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends a review of those images. Images can be previewed through a mobile application. JBS-LVO is intended to analyze terminal ICA and MCA-M1 vessels for LVOs. Images that are previewed through the mobile application are compressed and for informational purposes only. They are not intended for diagnostic use beyond notification. The JBS-LVO device does not alter the original medical image. 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. JBS-LVO is limited to the analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm a diagnosis. Limitations: The device does not process scans containing metallic artifacts.

Source page: https://510kreport.com/device/K241480
Methodology: https://510kreport.com/methodology