# K152567: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Nov 6, 2015 after 58 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: 19 generations back to K935595 (1995). 121 ancestors in all.
154 later devices descend from it; 4 cite it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142472: Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems, GE Healthcare (2015) Summary page 25.

## Most influential descendants
- K160184: Voluson S6, Voluson S8, Voluson S10 (2016), 55 descendants of its own
- K162267: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2016), 53 descendants of its own
- K161706: Vivid iq (2016), 46 descendants of its own
- K162269: Voluson E6, Voluson E8, Voluson E10 (2016), 41 descendants of its own
- K180599: Venue (2018), 28 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/K152567
Methodology: https://510kreport.com/methodology