# K120201: GE Vivid E9 Diagnostic Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Vingmed Ultrasound AS
- Decided: Apr 19, 2012 after 87 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003931 (2001). 16 ancestors in all.
253 later devices descend from it; 2 cite it directly.
0 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101149: GE Vivid E9 Diagnostic Ultrasound Imaging System, Ge Vingmed Ultrasound AS (2010) Summary page 1.
- K102388: Vivid I Diagnostic Ultrasound System, Ge Medical System Israel, Ltd. (2010) Summary page 1.
- K081921: GE Vivid E9 Ultrasound, General Electric Co. (2008) Summary page 1.

## Most influential descendants
- K131514: GE Vivid E9 Diagnostic Ultrasound Imaging System (2013), 167 descendants of its own
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0 (2015), 100 descendants of its own
- K132341: DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems (2013), 96 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

## Recalls of this device
- Oct 11, 2013 · Class II · Z-0373-2014: GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner ma

## 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/K120201
Methodology: https://510kreport.com/methodology