# K180883: 5D Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: May 15, 2018 after 41 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: 26 generations back to K924432 (1993). 236 ancestors in all.
No later device cites it as a predicate yet.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161955: 5D Viewer, Samsung Medison Co., Ltd. (2016) Summary page 4.
- K171070: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2017) Summary page 4.

## Indications for use
5D Viewer is a software application for the display and 3D visualization of US Volume Data measured by an ultrasound system. This application is designed to allow the user to examine and analyze images based on volume data received from the specified ultrasound diagnostic system. It may also be used to search, analyze, edit, measure, and store the volume data.

Source page: https://510kreport.com/device/K180883
Methodology: https://510kreport.com/methodology