# K161955: 5D Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Aug 10, 2016 after 23 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: 24 generations back to K924432 (1993). 209 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151808: 3D/5D Viewer, Samsung Medison Co., Ltd. (2015) Summary page 4.
- K153529: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2016) Summary page 4.
- K151663: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K172513: 3D Echo (2017), 1 descendant of its own
- K211656: 3D Echo v1.1 (2021), 0 descendants of its own
- K180883: 5D Viewer (2018), 0 descendants of its own

## Indications for use
5D Viewer is a software application for the display and 3D visualization of ultrasound volume data derived from ultrasound system. It is designed to allow the user to observe images and perform analysis using the ultrasound volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, analyzing, editing, measuring and storing of volume data. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K161955
Methodology: https://510kreport.com/methodology