# K242556: JLK-CTP

- Pathway: 510(k) (Traditional)
- Applicant: JLK, Inc.
- Decided: Oct 16, 2024 after 49 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-CTP 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 CT perfusion images for the brain. Data and images are acquired through DICOM compliant imaging devices. JLK-CTP provides both viewing and analysis capabilities for dynamic imaging datasets obtained through CT Perfusion protocols. The analysis is for visualization and examination of imaging data, revealing characteristics of contrast changes over time. This functionality includes the calculation of CT perfusion parameters associated with tissue flow (perfusion) and tissue blood volume.

Source page: https://510kreport.com/device/K242556
Methodology: https://510kreport.com/methodology