K253720
- 510(k) number
- K253720
- Device name
- uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
- Applicant
- Wuhan United Imaging Healthcare Co.,Ltd CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-05-21
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253720.pdf
Official FDA record: K253720
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.