# K243611: JLK-SDH

- Pathway: 510(k) (Traditional)
- Applicant: JLK, Inc.
- Decided: Mar 3, 2025 after 101 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)
- K220439: Viz SDH, Viz. Ai, Inc. (2022) Summary page 5.

## Indications for use
JLK-SDH is a notification-only, parallel workflow tool that is intended to assist trained radiologists to identify and communicate images of specific patients to a specialist, independent of the standard of care workflow. JLK-SDH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate user of these findings in parallel to 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 for subdural hemorrhage (SDH) and sends notifications to a clinician that a suspected SDH has been identified and recommends a review of those images. Images can be previewed and compressed through PACS and mobile applications. 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. JLK-SDH 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/K243611
Methodology: https://510kreport.com/methodology