# K232381: LOGIQ Totus

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Dec 7, 2023 after 121 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.
1 later device descends from it; 1 cites it directly.
0 of 156 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
- K253370: LOGIQ Totus (2026), 0 descendants of its own

## Indications for use
The LOGIQ Totus 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 Totus 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. 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, Contrast, Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD. B/Color/PWD, B/Power/PWD. The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office(Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician’s Office. Labor/Deliver Unit and Oncology.

Source page: https://510kreport.com/device/K232381
Methodology: https://510kreport.com/methodology