# K251963: LOGIQ E10s

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Oct 29, 2025 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: 23 generations back to K935595 (1995). 155 ancestors in all.
No later device cites it as a predicate yet.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231989: LOGIQ E10s, LOGIQ Fortis, Ge Medical Systems Ultrasound and Primary Care Diagnostic, (2023) Summary page 5.

## Indications for use
The LOGIQ E10s is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology I 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 lntraoperative (Abdominal and Vascular). Modes of operation include: 8, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 30/40 Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: 8/M, 8/Color, 8/PWD, 8/Color/PWD, 8/Power/PWD. The LOGIQ E10s is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K251963
Methodology: https://510kreport.com/methodology