Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2026, with 33 FDA device recalls on record.
Top product codes for Shanghai United Imaging Healthcare Co., Ltd.
FDA recalls by Shanghai United Imaging Healthcare Co., Ltd.
10 most recent of 33- Z-3277-2026 — Computed Tomography X-ray System, Model: uCT 530 with software
- Z-3278-2026 — Computed Tomography X-ray System, Model: uCT 550 with software
- Z-3284-2026 — Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
- Z-3287-2026 — Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
- Z-3280-2026 — Computed Tomography X-ray System, Model: uCT 780 with software
- Z-3281-2026 — Computed Tomography X-ray System, Model: uCT ATLAS with software
- Z-3282-2026 — Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
- Z-3286-2026 — Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
- Z-3285-2026 — Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
- Z-3279-2026 — Computed Tomography X-ray System, Model: uCT 760 with software
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Shanghai United Imaging Healthcare Co., Ltd.
- K261676 — uPMR Zenith
- K253726 — uAngio AVIVA CX
- K261427 — uMI Panvivo (uMI Panvivo M)
- K260113 — uMR Astra
- K253077 — uOmnispace.MR
- K260524 — uMI Panvivo (5 models)
- K253564 — uMI Panvivo (4 models)
- K253173 — uCT 780 with uWS-CT-Dual Energy Analysis
- K252000 — uDR Arria & uDR Aris
- K252371 — uMR 680
- K250045 — uWS-Angio Pro
- K251167 — uDR Aurora CX
- K250040 — uWS-Angio
- K250246 — uMR Jupiter
- K243547 — uMR Ultra
- K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
- K243397 — uMR 680
- K243666 — uOmniscan
- K243122 — uMR Omega
- K243617 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
- K242624 — Medical Image Post-processing Software (uOmnispace.CT)
- K243632 — uWS-Angio Basic
- K243376 — uAngio AVIVA CX
- K241166 — uCT 550
- K241079 — uCT 780
- K243538 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
- K241068 — uDR 780i
- K242515 — uDR 380i Pro
- K241585 — uMI Panorama
- K241596 — uMI Panvivo
- K234154 — uPMR 790
- K233209 — uOmnispace.CT
- K233673 — uMR Jupiter
- K233186 — uOmnispace.MR
- K240744 — uMR 680
- K240540 — uMR Omega
- K231762 — uEXPLORER
- K233176 — uOmnispace.MI
- K231482 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
- K232712 — uMI Panorama
- K230162 — uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
- K231572 — uMI Panorama
- K230039 — uOmnispace
- K230152 — uMR Omega
- K230758 — uMR 570
- K223325 — uMI Panorama
- K223028 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
- K222540 — uPMR 790
- K220332 — uMR Omega with uWS-MR-MRS
- K222339 — uDR 380i Pro
- K203448 — uCT ATLAS with uWS-CT-Dual Energy Analysis
- K210001 — HYPER AiR
- K210418 — HYPER Focus
- K193210 — HYPER DLR
- K193073 — Deep Recon
- K201540 — uMR570
- K192630 — uWS-MI
- K192601 — uWS-MR
- K193176 — uMR 780
- K200024 — uMR 570
- K193200 — uMR Omega
- K200016 — uCT 530, uCT 550
- K193241 — Emission Computed Tomography System
- K183144 — uMC 560i
- K192672 — uPMR 790
- K192293 — uDR 592h, uDR 596i
- K183170 — uWS-CT
- K191157 — uMR 780, uMR 790
- K183164 — uWS-MR
- K183014 — uPMR 790
- K183186 — Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24
- K183137 — uMR 580, uMR 588
- K182938 — Emission Computed Tomography System
- K172999 — uWS-MR
- K173001 — uWS-CT
- K182237 — uMI 550 PET/CT System
- K181370 — uMR 780
- K181371 — uMR 790
- K181414 — uCT 530, uCT 550
- K181413 — uDR 592h, uDR 596i
- K180925 — uMR 570
- K180926 — uMR 560
- K172143 — uMI 780 PET/CT System
- K172998 — uWS-MI
- K172135 — uCT Computed Tomography X-ray System
- K173953 — uDR 780i
Data sourced from openFDA. This site is unofficial and independent of the FDA.