# K250348: JLK-AILink

- Pathway: 510(k) (Traditional)
- Applicant: JLK, Inc.
- Decided: Feb 25, 2025 after 19 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: 2 generations back to K010259 (2001). 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)
- K031013: Infintt CO., LTD. Starpacs System, Infinitt Company (2003) Summary page 5.

## Indications for use
JLK-AILink is a software that receives digital images and data from various sources (i.e., CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and analyzed data with optional modules can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals including but not limited to physicians and medical technicians. The device is not intended for mammography.

Source page: https://510kreport.com/device/K250348
Methodology: https://510kreport.com/methodology