# K180704: SonoSite iViz Ultrasound System

- Pathway: 510(k) (Abbreviated)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Apr 13, 2018 after 25 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: 20 generations back to K935595 (1995). 201 ancestors in all.
2 later devices descend from it; 2 cite it directly.
6 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162288: SonoSite iViz Ultrasound System, FUJIFILM Sonosite, Inc. (2016) Summary page 4.
- K133454: Sonosite Edge Ultrasound System, FUJIFILM Sonosite, Inc. (2013) Summary page 5.
- K162045: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System, FUJIFILM Sonosite, Inc. (2016) Summary page 5.

## Most influential descendants
- 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 SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include: Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic

Source page: https://510kreport.com/device/K180704
Methodology: https://510kreport.com/methodology