# K151028: LOGIQ e

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jun 18, 2015 after 62 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). 132 ancestors in all.
60 later devices descend from it; 12 cite it directly.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133533: Logiq E, GE Healthcare (2014) Summary page 4.
- K113690: GE Logiq I, Logiq E and Vivid E, GE Healthcare (2011) Summary page 4.

## Most influential descendants
- K160277: LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 (2016), 47 descendants of its own
- K161706: Vivid iq (2016), 46 descendants of its own
- K170714: Venue (2017), 35 descendants of its own
- K180599: Venue (2018), 28 descendants of its own
- K183362: Venue GO (2019), 14 descendants of its own

## Indications for use
The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: ophthalmic: fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult & pediatric); peripheral vascular; musculoskeletal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access).

Source page: https://510kreport.com/device/K151028
Methodology: https://510kreport.com/methodology