# K231989: LOGIQ E10s, LOGIQ Fortis

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Ultrasound and Primary Care Diagnostic,
- Decided: Nov 7, 2023 after 125 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: 22 generations back to K935595 (1995). 154 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211524: LOGIQ E10s, LOGIQ Fortis, GE Healthcare (2021) Summary page 4.

## Most influential descendants
- K253366: LOGIQ Fortis (2026), 2 descendants of its own
- K261835: LOGIQ Focus (2026), 0 descendants of its own
- K260673: LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power (2026), 0 descendants of its own
- K251985: Logiq E10 (2025), 0 descendants of its own
- K251963: LOGIQ E10s (2025), 0 descendants of its own

## Indications for use
The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s and LOGIQ Fortis 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 (Abdominal, 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 and LOGIQ Fortis are intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K231989
Methodology: https://510kreport.com/methodology