Shanghai United Imaging Healthcare Co., Ltd. - FDA 510(k) Cleared Dev...
80
Total
80
Cleared
0
Denied
80 devices
Cleared
May 17, 2024
uOmnispace.CT
Radiology
232d
Cleared
Apr 26, 2024
uMR Jupiter
Radiology
162d
Cleared
Apr 17, 2024
uOmnispace.MR
Radiology
202d
Cleared
Apr 10, 2024
uMR 680
Radiology
23d
Cleared
Mar 22, 2024
uMR Omega
Radiology
25d
Cleared
Jan 18, 2024
uEXPLORER
Radiology
216d
Cleared
Dec 20, 2023
uOmnispace.MI
Radiology
83d
Cleared
Nov 29, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with...
Radiology
190d
Cleared
Oct 03, 2023
uMI Panorama
Radiology
28d
Cleared
Aug 01, 2023
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy...
Radiology
193d
Cleared
Jul 26, 2023
uMI Panorama
Radiology
56d
Cleared
Jul 20, 2023
uOmnispace
Radiology
195d
Cleared
May 23, 2023
uMR Omega
Radiology
124d
Cleared
May 18, 2023
uMR 570
Radiology
59d
Cleared
Mar 10, 2023
uMI Panorama
Radiology
130d
Cleared
Feb 16, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Radiology
140d
Cleared
Nov 14, 2022
uPMR 790
Radiology
84d
Cleared
Oct 27, 2022
uMR Omega with uWS-MR-MRS
Radiology
265d
Cleared
Sep 30, 2022
uDR 380i Pro
Radiology
58d
Cleared
Aug 11, 2021
uCT ATLAS with uWS-CT-Dual Energy Analysis
Radiology
261d
Cleared
Apr 30, 2021
HYPER AiR
Radiology
116d
Cleared
Apr 09, 2021
HYPER Focus
Radiology
57d
Cleared
Aug 04, 2020
HYPER DLR
Radiology
257d
Cleared
Jul 06, 2020
Deep Recon
Radiology
245d
Cleared
Jul 06, 2020
uMR570
Radiology
27d
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