uMI Panvivo (4 models)— 510(k) K253564

Name: FDA 510(k) clearance K253564
Creator: U.S. Food and Drug Administration
Published: 2026-02-13

Substantially Equivalent

Shanghai 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.

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: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2025-11-17
Decision date: 2026-02-13
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
K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) +1 more2026-01-13

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

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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
K252000 — uDR Arria & uDR Aris2025-11-26

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