# K180549: ZED Link

- Pathway: 510(k) (Traditional)
- Applicant: Zed Technologies
- Decided: Apr 12, 2018 after 42 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: 7 generations back to K954678 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151957: BOX DICOM Viewer, Box, Inc. (2015) Summary page 4.

## Indications for use
ZED LINK™, is an image management system whose intended use is to provide scalable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all image modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation” and will include standard features and other tools for analyzing mammography images. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. ZED LINK™, is not intended for diagnostic image review on mobile devices. Typical users of this system are doctors and health care professionals.

Source page: https://510kreport.com/device/K180549
Methodology: https://510kreport.com/methodology