# K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System

- Pathway: 510(k) (Special)
- Applicant: Ge Vingmed Ultrasound AS
- Decided: Jul 12, 2013 after 45 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 130 ancestors in all.
167 later devices descend from it; 6 cite it directly.
0 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120201: GE Vivid E9 Diagnostic Ultrasound Imaging System, Ge Vingmed Ultrasound AS (2012) Summary page 1.
- K031663: GE Vivid 7, Model FC0003XX, General Electric Co. (2003) Summary page 1.
- K123564: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2012) Summary page 1.
- K120221: GE Echopac, GE Healthcare (2012) Summary page 1.

## Most influential descendants
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2015), 100 descendants of its own
- K141093: 6VT-D Ultrasound Transducer (2014), 85 descendants of its own
- K142323: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System (2014), 84 descendants of its own
- K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2016), 73 descendants of its own
- K150087: Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System (2015), 73 descendants of its own

## Recalls of this device
- Mar 22, 2018 · Class II · Z-2985-2018: The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
- Mar 27, 2014 · Class II · Z-1488-2014: GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a si

## Indications for use
GE Vivid E9 ultrasound system 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; 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; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Source page: https://510kreport.com/device/K131514
Methodology: https://510kreport.com/methodology