uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)— 510(k) K251839

Name: FDA 510(k) clearance K251839
Creator: U.S. Food and Drug Administration
Published: 2025-07-17

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K251839 for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S), Substantially Equivalent on 2025-07-17. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

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: 2025-06-16
Decision date: 2025-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

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K261305 — MICSI-PET2026-09-11
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
K260524 — uMI Panvivo (5 models)2026-04-03
K253564 — uMI Panvivo (4 models)2026-02-13

More clearances from Shanghai United Imaging Healthcare Co., Ltd.

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K261676 — uPMR Zenith2026-10-28
K253726 — uAngio AVIVA CX2026-08-21
K260113 — uMR Astra2026-05-22
K253077 — uOmnispace.MR2026-04-22
K253173 — uCT 780 with uWS-CT-Dual Energy Analysis2026-01-20

Recalls naming K251839

K-number listed on FDA's recall record

Z-3287-2026 — Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with softwareClass II·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·20260811
Z-3286-2026 — Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with softwareClass II·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·20260811

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K251839.

Data sourced from openFDA. This site is unofficial and independent of the FDA.