# K152983: FUJIFILM SonoSite iViz Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Nov 12, 2015 after 34 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 191 ancestors in all.
5 later devices descend from it; 1 cites it directly.
6 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133454: Sonosite Edge Ultrasound System, FUJIFILM Sonosite, Inc. (2013) Summary page 6.
- K133833: Nuvis Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2014) Summary page 6.

## Most influential descendants
- K161119: SonoSite iViz Ultrasound System (2016), 4 descendants of its own
- K162288: SonoSite iViz Ultrasound System (2016), 3 descendants of its own
- K180704: SonoSite iViz Ultrasound System (2018), 2 descendants of its own
- K260595: Sonosite iLOOK Ultrasound System (2026), 0 descendants of its own
- K202160: Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System (2020), 0 descendants of its own

## Indications for use
The FUJIFILM SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal - OB Abdominal Pediatric Cardiac Adult Cardiac Pediatric

Source page: https://510kreport.com/device/K152983
Methodology: https://510kreport.com/methodology