uMI Panvivo (uMI Panvivo M)— 510(k) K261427
Substantially EquivalentShanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) clearance K261427 for uMI Panvivo (uMI Panvivo M), Substantially Equivalent on 2026-07-28. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.
Summary
Shanghai United Imaging Healthcare's uMI Panvivo (uMI Panvivo M) is filed under KPS, emission computed tomography systems. The record doesn't say what distinguishes the M version.
Class II, 21 CFR 892.1200. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
United Imaging filed from Shanghai, China. The decision came 89 calendar days after FDA received it (April 30 to July 28, 2026).
Clearance details
- 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
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