# K242161: Radlink GPS Pro Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Radlink, Inc.
- Decided: Mar 18, 2025 after 237 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: 12 generations back to K896095 (1990). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231503: CUPTIMIZE™ Advanced, DePuy Orthopaedics, Inc. (2023) Summary page 5.
- K142718: Radlink GPS, Radlink, Inc. (2014) Summary page 5.

## Indications for use
Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum’s position relative to local bone structures identified from radiological images. The device allows for overlaying digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

Source page: https://510kreport.com/device/K242161
Methodology: https://510kreport.com/methodology