# K230511: K3900 Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Maui Imaging
- Decided: Oct 25, 2023 after 243 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 4.

## Indications for use
The K3900 Ultrasound Imaging System is intended for use by a qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular). Modes of operation: B-Mode.

Source page: https://510kreport.com/device/K230511
Methodology: https://510kreport.com/methodology