# K253370: LOGIQ Totus

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jan 8, 2026 after 100 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)
- K232381: LOGIQ Totus, GE Medical Systems Ultrasound and Primary Care Diagnostics (2023) Summary page 5.

## Indications for use
LOGIQ Totus 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 lntraoperative(Abdominal and Vascular). Modes of operation includes: 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 Totus is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K253370
Methodology: https://510kreport.com/methodology