# K192159: Voluson E6, Voluson E8, Voluson E10

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Aug 29, 2019 after 20 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: 23 generations back to K935595 (1995). 168 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181985: Voluson E6, Voluson E8, Voluson E10, GE Healthcare (2018) Summary page 6.

## Most influential descendants
- K201768: Voluson E10 (2020), 4 descendants of its own
- K220358: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 (2022), 3 descendants of its own
- K231965: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 (2023), 2 descendants of its own
- K242168: Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (2024), 1 descendant of its own
- K252328: Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (2025), 0 descendants of its own

## Indications for use
The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal.

Source page: https://510kreport.com/device/K192159
Methodology: https://510kreport.com/methodology