FDA 510(k) clearance · back to tracker

uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite

Wuhan United Imaging Healthcare Co.,Ltd cleared K253720 on 2026-05-21, decision: substantially equivalent

K-number

K253720

Sponsor

Wuhan United Imaging Healthcare Co.,Ltd

Device

uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-21

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K253720on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K253720 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.