Medical Device Manufacturer · CN , Shanghai

Shanghai United Imaging Healthcare Co., Ltd. - FDA 510(k) Cleared Dev...

83 submissions · 83 cleared · Since 2018

Recent clearances: uMR Astra, uOmnispace.MR, uMI Panvivo (uMI Panvivo LS)

Official Website

83

Total

83

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shanghai United Imaging Healthcare Co., Ltd. Radiology ✕

83 devices

1-12 of 83

Cleared May 22, 2026

Radiology · 128d

Cleared Apr 22, 2026

Radiology · 211d

Cleared Apr 03, 2026

uMI Panvivo (uMI Panvivo LS)

Radiology · 45d

Cleared Feb 13, 2026

uMI Panvivo (uMI Panvivo)

Radiology · 88d

Cleared Jan 20, 2026

uCT 780 with uWS-CT-Dual Energy Analysis

Radiology · 116d

Cleared Nov 26, 2025

uDR Arria & uDR Aris

Radiology · 152d

Cleared Sep 25, 2025

Radiology · 57d

Cleared Sep 24, 2025

Radiology · 257d

Cleared Sep 19, 2025

Radiology · 157d

Cleared Sep 12, 2025

Radiology · 247d

Cleared Aug 05, 2025

Radiology · 190d

Cleared Jul 17, 2025

Radiology · 244d

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