# K181985: Voluson E6, Voluson E8, Voluson E10

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Nov 15, 2018 after 113 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K935595 (1995). 167 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172342: Voluson E6, Voluson E8, Voluson E10, GE Healthcare (2017) Summary page 29.
- K173555: Logiq E10, GE Healthcare (2017) Summary page 28.

## Most influential descendants
- K192505: HS50/HS60 Diagnostics Ultrasound System (2019), 10 descendants of its own
- K200339: HS40 Diagnostic Ultrasound System (2020), 8 descendants of its own
- K192159: Voluson E6, Voluson E8, Voluson E10 (2019), 5 descendants of its own
- K210713: HM70 EVO Diagnostic Ultrasound System (2021), 4 descendants of its own
- K201768: Voluson E10 (2020), 4 descendants of its own

## Recalls of this device
- Jul 2, 2019 · Class II · Z-1964-2019: Potential for a transducer mis-alignment in certain transvaginal probes.

## 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/K181985
Methodology: https://510kreport.com/methodology