uMI Panvivo (4 models)— 510(k) K253564
Substantially EquivalentShanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) clearance K253564 for uMI Panvivo (4 models), Substantially Equivalent on 2026-02-13. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.
Summary
Shanghai United Imaging Healthcare lists four uMI Panvivo entries: uMI Panvivo, uMI Panvivo S, uMI Panvivo EX, and uMI Panvivo ES. They're filed under product code KPS (System, Tomography, Computed, Emission), and the record doesn't say how the four differ.
Class II, 21 CFR 892.1200. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Shanghai United Imaging Healthcare filed from Shanghai, China. FDA found it substantially equivalent 88 calendar days after receipt (November 17, 2025 to February 13, 2026).
Clearance details
- Device name as filed
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Product code
- Product code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code KPS
view allMore clearances from Shanghai United Imaging Healthcare Co., Ltd.
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