uMI Panvivo (5 models)— 510(k) K260524

Name: FDA 510(k) clearance K260524
Creator: U.S. Food and Drug Administration
Published: 2026-04-03

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K260524 for uMI Panvivo (5 models), Substantially Equivalent on 2026-04-03. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: uMI Panvivo (uMI Panvivo LS); 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: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2026-02-17
Decision date: 2026-04-03
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
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K253564 — uMI Panvivo (4 models)2026-02-13
K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) +1 more2026-01-13

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K252000 — uDR Arria & uDR Aris2025-11-26

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