# K113758: Voluson E6/E8/E8EXPERT/E10

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jan 10, 2012 after 20 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003525 (2000). 6 ancestors in all.
402 later devices descend from it; 5 cite it directly.
0 of 409 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112213: Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System, GE Healthcare (2011)

## Most influential descendants
- K122327: Voluson E6/E8/E8EXPERT/E10 (2012), 365 descendants of its own
- K123564: Logiq E9 Diagnostic Ultrasound System (2012), 323 descendants of its own
- K120741: Voluson S6, Voluson S8 (2012), 295 descendants of its own
- K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 (2013), 270 descendants of its own
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), 263 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; and Intraoperative (abdominal, PV and neurological).

Source page: https://510kreport.com/device/K113758
Methodology: https://510kreport.com/methodology