# K242709: JLK-Pwi

- Pathway: 510(k) (Traditional)
- Applicant: JLK, Inc.
- Decided: Nov 4, 2024 after 56 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K896095 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121447: Ischema View Rapid, Ischemaview, Inc. (2013) Summary page 5.

## Indications for use
JLK-PWI is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of Diffusion-weighted imaging (DWI) and Perfusion-weighted imaging (PWI) images for the brain from Magnetic Resonance Imaging (MRI) systems. Data and images are acquired through DICOM-compliant imaging devices. JLK-PWI provides both viewing and analysis capabilities for dynamic imaging datasets obtained through MRI protocols. The DWI analysis capabilities are used to analyze local water diffusion properties from diffusion-weighted MRI data. The PWI analysis capabilities are for analyzing dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculating parameters related to tissue flow (perfusion) and tissue blood volume.

Source page: https://510kreport.com/device/K242709
Methodology: https://510kreport.com/methodology