# K173341: Vivid E80, Vivid E90, Vivid E95

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 2, 2017 after 9 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K935595 (1995). 219 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170823: Vivid E80, Vivid E90, Vivid E95, GE Medical Systems Ultrasound and Primary Care Diagnostics (2017) Summary page 5.

## Most influential descendants
- K181685: Vivid E80, Vivid E90, Vivid E95 (2018), 13 descendants of its own
- K182450: Vivid S60N, Vivid S70N (2018), 9 descendants of its own
- K200743: Vivid E80/ Vivid E90/ Vivid E95 (2020), 7 descendants of its own
- K202658: Vivid E80/ Vivid E90/ Vivid E95 (2021), 5 descendants of its own
- K201768: Voluson E10 (2020), 4 descendants of its own

## Recalls of this device
- Mar 22, 2018 · Class II · Z-2986-2018: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
- Mar 22, 2018 · Class II · Z-2987-2018: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
- Mar 22, 2018 · Class II · Z-2988-2018: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

## Indications for use
Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Source page: https://510kreport.com/device/K173341
Methodology: https://510kreport.com/methodology