# K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jun 19, 2013 after 47 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: 16 generations back to K935595 (1995). 118 ancestors in all.
270 later devices descend from it; 3 cite it directly.
0 of 389 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122327: Voluson E6/E8/E8EXPERT/E10, GE Healthcare (2012) Summary page 1.
- K120741: Voluson S6, Voluson S8, GE Healthcare (2012) Summary page 1.

## Most influential descendants
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 (2013), 255 descendants of its own
- K142472: Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems (2015), 187 descendants of its own
- K152567: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System (2015), 154 descendants of its own
- K141639: Voluson S6, Voluson S8 (2014), 151 descendants of its own
- K143452: Logiq P9, Logiq P7 (2015), 131 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; Transrectal

Source page: https://510kreport.com/device/K131267
Methodology: https://510kreport.com/methodology