# K102393: Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical System Israel, Ltd.
- Decided: Nov 5, 2010 after 74 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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: 4 generations back to K000695 (2000). 4 ancestors in all.
177 later devices descend from it; 1 cites it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092079: Modification to GE Vivid S5 and S6 Diagnostic Ultrasound, Ge Medical Systems Israel, Ultrasound, Ltd. (2009) Summary page 2.

## Most influential descendants
- K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System (2012), 176 descendants of its own
- 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

## 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; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). Ultrasound imaging, measurement and analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K102393
Methodology: https://510kreport.com/methodology