# K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Nov 17, 2016 after 14 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: 18 generations back to K935595 (1995). 150 ancestors in all.
73 later devices descend from it; 5 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 40.

## Most influential descendants
- K173555: Logiq E10 (2017), 38 descendants of its own
- K170823: Vivid E80, Vivid E90, Vivid E95 (2017), 35 descendants of its own
- K173341: Vivid E80, Vivid E90, Vivid E95 (2017), 20 descendants of its own
- K181985: Voluson E6, Voluson E8, Voluson E10 (2018), 17 descendants of its own
- K181685: Vivid E80, Vivid E90, Vivid E95 (2018), 13 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).

Source page: https://510kreport.com/device/K163077
Methodology: https://510kreport.com/methodology