uEXPLORER— 510(k) K231762

Name: FDA 510(k) clearance K231762
Creator: U.S. Food and Drug Administration
Published: 2024-01-18

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K231762 for uEXPLORER, Substantially Equivalent on 2024-01-18. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

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: 2023-06-16
Decision date: 2024-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

view all

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.

view all

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

Recalls naming K231762

K-number listed on FDA's recall record

Z-0222-2026 — Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx OnlyClass II·Ongoing·UIH Technologies LLC·20250912

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K231762.

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