# K261835: LOGIQ Focus

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jul 30, 2026 after 58 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: 24 generations back to K935595 (1995). 156 ancestors in all.
No later device cites it as a predicate yet.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253366: LOGIQ Fortis, GE Medical Systems Ultrasound and Primary Care Diagnostics (2026) Summary page 5.

## Indications for use
LOGIQ Focus is a general-purpose diagnostic ultrasound system intended for qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The system is intended for use for the following Part of Body or Type of Tissue: Fetal/Obstetrical, Abdominal (including Renal, Gynecology/Pelvic, Thoracic/Pleural), Pediatric, Small Organ (Breast, Testes, Thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional and Superficial, Urology (including prostate), Transrectal, Transvaginal, Transesophageal and Intraoperative (Vascular), Interventional Guidance (including tissue biopsy, fluid drainage, vascular and nonvascular access). 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. LOGIQ Focus is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K261835
Methodology: https://510kreport.com/methodology