uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
FDA 510(k) clearance K253720 · decided 2026-05-21
Clearance details
- 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
- Decision
- Substantially Equivalent
- Date received
- 2025-11-24
- Decision date
- 2026-05-21
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wuhan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.