# K232186: LOGIQ e

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Ultrasound and Primary Care Diagnostic,
- Decided: Nov 3, 2023 after 102 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: 19 generations back to K935595 (1995). 133 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151028: LOGIQ e, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 4.

## Most influential descendants
- K260398: LOGIQ e (2026), 0 descendants of its own

## Indications for use
The LOGIQ e is a general purpose diagnostic ultrasound system for use by qualified and trained HealthCare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ e is intended to be used in a hospital or medical clinic. LOGIQ e clinical application include: 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). Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

Source page: https://510kreport.com/device/K232186
Methodology: https://510kreport.com/methodology