# K133454: Sonosite Edge Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Dec 16, 2013 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: 9 generations back to K945773 (1995). 50 ancestors in all.
50 later devices descend from it; 11 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113156: Sonosite Edge Ultrasound System, Sonosite,Inc. (2011) Summary page 1.
- K130173: Sonosite Maxx Series Ultrasound System, FUJIFILM Sonosite, Inc. (2013) Summary page 1.

## Most influential descendants
- K142017: X-Porte Ultrasound System (2014), 46 descendants of its own
- K152209: FUJIFILM SonoSite X-Porte Ultrasound System (2015), 45 descendants of its own
- K153626: SonoSite Edge II Ultrasound System (2016), 42 descendants of its own
- K163138: Clarius Ultrasound System (2016), 28 descendants of its own
- K172385: Clarius Ultrasound System (2017), 22 descendants of its own

## Indications for use
The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician 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 Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) 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 Trans-esophageal (cardiac) Peripheral Vessel

Source page: https://510kreport.com/device/K133454
Methodology: https://510kreport.com/methodology