# K253720: uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan United Imaging Healthcare Co.,Ltd
- Decided: May 21, 2026 after 178 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 5.

## 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/K253720
Methodology: https://510kreport.com/methodology