# K253716: uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan United Imaging Healthcare Co.,Ltd
- Decided: May 15, 2026 after 172 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)
- K231966: Logiq E10, GE Medical Systems Ultrasound and Primary Care Diagnostics (2023) Summary page 6.

## Indications for use
The Ultrasonic Pulsed Doppler Imaging System is used for ultrasound scanning of the whole body. It is intended for use by qualified and trained healthcare professionals in a hospital or medical clinic to perform ultrasound diagnostic examinations, supporting the following clinical applications: Abdominal (including Renal, Gynecological, and Obstetric), Pediatric, Small Parts, Cranial(Neonatal Cephalic, Adult Cephalic), Cardiac, Peripheral Vascular, Musculoskeletal, Urological. Modes of operation include: B Mode, M Mode, Color Mode, PW Mode, CW Mode, 3D/4D Mode, Strain Elastography Imaging, Shear Wave Elastography Imaging. Combined modes: B/M, B/Color, B/PW, B/Color/PW.

Source page: https://510kreport.com/device/K253716
Methodology: https://510kreport.com/methodology