# K243363: JLK-Ich

- Pathway: 510(k) (Traditional)
- Applicant: JLK, Inc.
- Decided: Jan 3, 2025 after 66 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.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193658: Viz ICH, Viz. Ai, Inc. (2020) Summary page 5.

## Indications for use
JLK-ICH is a radiological computer-aided triage and notification software indicated for use in the analysis of non-contrast CT images. JLK-ICH is a notification-only, parallel workflow tool that is intended to assist hospital networks and trained clinicians to identify and communicate images of specific patients to specialists, independent of the standard of care workflow. JLK-ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of pre-specified clinical conditions and promptly notifies the appropriate medical specialists of these findings in parallel with the standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes non-contrast CT images of the head to detect intracranial hemorrhage (ICH). The system sends a notification to a clinician that a suspected ICH has been identified and recommends a review of those images. Images can be previewed and compressed through a mobile application. 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 clinician before making care-related decisions or requests. JLK-ICH 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 the diagnosis.

Source page: https://510kreport.com/device/K243363
Methodology: https://510kreport.com/methodology