# K211488: Logiq E10

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 10, 2021 after 120 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: 21 generations back to K935595 (1995). 153 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200158: Logiq E10, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2020) Summary page 4.

## Most influential descendants
- K231966: Logiq E10 (2023), 5 descendants of its own
- K220940: EchoPAC Software Only, EchoPAC Plug-in (2022), 2 descendants of its own
- K251342: EchoPAC Software Only / EchoPAC Plug-in (2025), 1 descendant of its own
- K242168: Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (2024), 1 descendant of its own
- K261623: EchoPAC Software Only / EchoPAC Plug-in (v211) (2026), 0 descendants of its own

## Indications for use
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of 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 (Abdominal and 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 E10 is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K211488
Methodology: https://510kreport.com/methodology