# K162045: SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Aug 18, 2016 after 24 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: 14 generations back to K945773 (1995). 57 ancestors in all.
11 later devices descend from it; 7 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153626: SonoSite Edge II Ultrasound System, FUJIFILM Sonosite, Inc. (2016) Summary page 4.
- K160734: SonoSite SII Ultrasound System, FUJIFILM Sonosite, Inc. (2016) Summary page 20.
- K133454: Sonosite Edge Ultrasound System, FUJIFILM Sonosite, Inc. (2013) Summary page 5.
- K160406: FUJIFILM FC1 Ultrasound System, FUJIFILM Sonosite, Inc. (2016) Summary page 7.

## Most influential descendants
- K171437: SonoSite X-Porte Ultrasound System (2017), 7 descendants of its own
- K200964: Sonosite PX Ultrasound System (2020), 6 descendants of its own
- K213763: Sonosite PX Ultrasound System (2021), 4 descendants of its own
- K233597: Sonosite LX Ultrasound System (2023), 3 descendants of its own
- K180704: SonoSite iViz Ultrasound System (2018), 2 descendants of its own

## Indications for use
The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use 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: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use 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: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Source page: https://510kreport.com/device/K162045
Methodology: https://510kreport.com/methodology