# K231930: Digital Ultrasonic Diagnostic Imaging System (Model: F6)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Youkey Medical Co., Ltd.
- Decided: Mar 22, 2024 after 266 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: 27 generations back to K935595 (1995). 325 ancestors in all.
No later device cites it as a predicate yet.
6 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211746: Pocket Ultrasound System, Guangdong Youkey Medical Co., Ltd. (2022) Summary page 5.

## Indications for use
Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a general use ultrasound device intended for use by appropriately qualified and trained healthcare professionals for ultrasound imaging, measurement, display and fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc.), Peripheral Vascular, Urology. Modes of operation include B mode, M mode, Color Doppler, Power Doppler, PWD and Combined (B+M; B+CD; B+PD; B+PWD). This system is suitable for use in hospital and clinical settings.

Source page: https://510kreport.com/device/K231930
Methodology: https://510kreport.com/methodology