uMI Panorama— 510(k) K231572

Name: FDA 510(k) clearance K231572
Creator: U.S. Food and Drug Administration
Published: 2023-07-26

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K231572 for uMI Panorama, Substantially Equivalent on 2023-07-26. 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: 2023-05-31
Decision date: 2023-07-26
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 K231572

K-number listed on FDA's recall record

Z-3285-2026 — Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS 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 K231572.

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