# K141639: Voluson S6, Voluson S8

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jul 18, 2014 after 29 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 128 ancestors in all.
151 later devices descend from it; 3 cite it directly.
0 of 280 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120741: Voluson S6, Voluson S8, GE Healthcare (2012) Summary page 1.
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10, GE Healthcare (2013) Summary page 1.
- K122387: Voluson P6, Voluson P8, GE Healthcare (2012) Summary page 1.
- K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System, Ge Medical System Israel, Ltd. (2012) Summary page 1.

## Most influential descendants
- K143452: Logiq P9, Logiq P7 (2015), 131 descendants of its own
- K161047: LOGIQ P9 and LOGIQ P7 (2016), 107 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K152195: Logiq S8 (2015), 57 descendants of its own
- K160184: Voluson S6, Voluson S8, Voluson S10 (2016), 55 descendants of its own

## Indications for use
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic: Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Source page: https://510kreport.com/device/K141639
Methodology: https://510kreport.com/methodology