# K162269: Voluson E6, Voluson E8, Voluson E10

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Oct 3, 2016 after 52 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: 20 generations back to K935595 (1995). 157 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152567: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System, GE Healthcare (2015) Summary page 27.
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 24.

## Most influential descendants
- K173090: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (2018), 21 descendants of its own
- K172342: Voluson E6, Voluson E8, Voluson E10 (2017), 18 descendants of its own
- K181985: Voluson E6, Voluson E8, Voluson E10 (2018), 17 descendants of its own
- K192505: HS50/HS60 Diagnostics Ultrasound System (2019), 10 descendants of its own
- K182679: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 (2018), 10 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/K162269
Methodology: https://510kreport.com/methodology