# K200119: LOGIQ E10s

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Apr 1, 2020 after 71 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: 20 generations back to K935595 (1995). 152 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173555: Logiq E10, GE Healthcare (2017) Summary page 4.

## Most influential descendants
- K211524: LOGIQ E10s, LOGIQ Fortis (2021), 8 descendants of its own
- K231989: LOGIQ E10s, LOGIQ Fortis (2023), 5 descendants of its own
- K253366: LOGIQ Fortis (2026), 2 descendants of its own
- K232381: LOGIQ Totus (2023), 1 descendant of its own
- K261835: LOGIQ Focus (2026), 0 descendants of its own

## Indications for use
The LOGIQ E10s is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s clinical applications include : Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); 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 (Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10s is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K200119
Methodology: https://510kreport.com/methodology