# K142718: Radlink GPS

- Pathway: 510(k) (Traditional)
- Applicant: Radlink, Inc.
- Decided: Dec 17, 2014 after 85 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K803130 (1981). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141440: Dicompacs DX-R with Flat Panel, Oehm Und Rehbein GmbH (2014) Summary page 5.
- K052938: CR-PRO, Eradlink, Inc. (2005) Summary page 5.
- K020243: Laserpro 16, Eradlink, Inc. (2002) Summary page 5.

## Most influential descendants
- K242161: Radlink GPS Pro Imaging (2025), 0 descendants of its own

## Indications for use
Radlink GPS is intended for digital image capture use in general radiographic examinations, whenever conventional screen-film systems may be used. Radlink GPS allows imaging of the pelvis, knee, skull, chest, shoulder, spine, abdomen and extremities. The digital images are transmitted from the panel or from a connection to PACS via computer networks or from a video input port to a personal computer (PC) where they may be displayed, processed, altered, overlaid with templates, compressed for archiving or transmission via computer networks to other medical facility sites. Not for mammography.

Source page: https://510kreport.com/device/K142718
Methodology: https://510kreport.com/methodology