# K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical System Israel, Ltd.
- Decided: Aug 21, 2012 after 137 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: 7 generations back to K003931 (2001). 12 ancestors in all.
176 later devices descend from it; 5 cite it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102393: Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound 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
- K141639: Voluson S6, Voluson S8 (2014), 151 descendants of its own
- K143452: Logiq P9, Logiq P7 (2015), 131 descendants of its own
- K161047: LOGIQ P9 and LOGIQ P7 (2016), 107 descendants of its own
- K142323: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System (2014), 84 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
- Nov 10, 2022 · Class II · Z-0752-2023: 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.
- Nov 10, 2022 · Class II · Z-0753-2023: 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 current modifications do not change the indications for use. As previously reported and cleared, the Vivid S5/S6 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; Transtectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Source page: https://510kreport.com/device/K121063
Methodology: https://510kreport.com/methodology