# K150087: Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Vingmed Ultrasound AS
- Decided: Mar 4, 2015 after 48 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 150 ancestors in all.
73 later devices descend from it; 4 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System, Ge Vingmed Ultrasound AS (2013) Summary page 5.
- K142323: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System, Ge Medical Systems Israel, Ltd. (2014) Summary page 14.
- K142160: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2014) Summary page 15.

## Most influential descendants
- K161706: Vivid iq (2016), 46 descendants of its own
- K170823: Vivid E80, Vivid E90, Vivid E95 (2017), 35 descendants of its own
- K180599: Venue (2018), 28 descendants of its own
- K173341: Vivid E80, Vivid E90, Vivid E95 (2017), 20 descendants of its own
- K172342: Voluson E6, Voluson E8, Voluson E10 (2017), 18 descendants of its own

## Recalls of this device
- May 2, 2024 · Class II · Z-2316-2024: GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultr
- 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.
- Mar 10, 2017 · Class II · Z-1780-2017: GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue i
- Mar 10, 2017 · Class II · Z-1779-2017: GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue i

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K150087
Methodology: https://510kreport.com/methodology