# K121062: Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical System Israel, Ltd.
- Decided: Aug 17, 2012 after 133 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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.
110 later devices descend from it; 3 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K161706: Vivid iq (2016), 46 descendants of its own
- K152543: M9/M9CV/M9T Diagnostic Ultrasound System (2015), 35 descendants of its own
- K180599: Venue (2018), 28 descendants of its own
- K163396: ACUSON P500 Ultrasound System (2017), 27 descendants of its own
- K180039: ACUSON P600 Diagnostic Ultrasound System (2018), 25 descendants of its own

## Recalls of this device
- Nov 10, 2022 · Class II · Z-0757-2023: Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

## Indications for use
The Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

Source page: https://510kreport.com/device/K121062
Methodology: https://510kreport.com/methodology