Company ยท CN
Shanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
85510(k) clearances (8 in 12 months)
33recalls (12 in 12 months)
33recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPS | System, Tomography, Computed, Emission | 32 |
| JAK | System, X-Ray, Tomography, Computed | 28 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 22 |
| LLZ | System, Image Processing, Radiological | 11 |
| KPR | System, X-Ray, Stationary | 9 |
| QIH | Automated Radiological Image Processing Software | 6 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 4 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 |
| IZL | System, X-Ray, Mobile | 2 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2026 | K253726 | uAngio AVIVA CX Shanghai United Imaging Healthcare Co., Ltd., CN | OWB |
| Jul 28, 2026 | K261427 | uMI Panvivo (uMI Panvivo M) Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| May 22, 2026 | K260113 | uMR Astra Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Apr 22, 2026 | K253077 | uOmnispace.MR Shanghai United Imaging Healthcare Co., Ltd., CN | QIH |
| Apr 3, 2026 | K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Feb 13, 2026 | K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Jan 20, 2026 | K253173 | uCT 780 with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Nov 26, 2025 | K252000 | uDR Arria & uDR Aris Shanghai United Imaging Healthcare Co., Ltd., CN | KPR |
| Sep 25, 2025 | K252371 | uMR 680 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Sep 24, 2025 | K250045 | uWS-Angio Pro Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Sep 19, 2025 | K251167 | uDR Aurora CX Shanghai United Imaging Healthcare Co., Ltd., CN | KPR |
| Sep 12, 2025 | K250040 | uWS-Angio Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Aug 5, 2025 | K250246 | uMR Jupiter Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Jul 17, 2025 | K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Jul 17, 2025 | K243547 | uMR Ultra Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Jul 16, 2025 | K243397 | uMR 680 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Jun 17, 2025 | K243666 | uOmniscan Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| May 21, 2025 | K243122 | uMR Omega Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| May 16, 2025 | K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| May 14, 2025 | K242624 | Medical Image Post-processing Software (uOmnispace.CT) Shanghai United Imaging Healthcare Co., Ltd., CN | QIH |
| May 12, 2025 | K243632 | uWS-Angio Basic Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Apr 28, 2025 | K243376 | uAngio AVIVA CX Shanghai United Imaging Healthcare Co., Ltd., CN | OWB |
| Jan 14, 2025 | K241166 | uCT 550 Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Jan 7, 2025 | K241079 | uCT 780 Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Dec 12, 2024 | K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Nov 1, 2024 | K241068 | uDR 780i Shanghai United Imaging Healthcare Co., Ltd., CN | KPR |
| Oct 10, 2024 | K242515 | uDR 380i Pro Shanghai United Imaging Healthcare Co., Ltd., CN | IZL |
| Aug 30, 2024 | K241585 | uMI Panorama Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Aug 15, 2024 | K241596 | uMI Panvivo Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| May 24, 2024 | K234154 | uPMR 790 Shanghai United Imaging Healthcare Co., Ltd., CN | OUO |
| May 17, 2024 | K233209 | uOmnispace.CT Shanghai United Imaging Healthcare Co., Ltd., CN | QIH |
| Apr 26, 2024 | K233673 | uMR Jupiter Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Apr 17, 2024 | K233186 | uOmnispace.MR Shanghai United Imaging Healthcare Co., Ltd., CN | QIH |
| Apr 10, 2024 | K240744 | uMR 680 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Mar 22, 2024 | K240540 | uMR Omega Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Jan 18, 2024 | K231762 | uEXPLORER Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Dec 20, 2023 | K233176 | uOmnispace.MI Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Nov 29, 2023 | K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Oct 3, 2023 | K232712 | uMI Panorama Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Aug 1, 2023 | K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Jul 26, 2023 | K231572 | uMI Panorama Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Jul 20, 2023 | K230039 | uOmnispace Shanghai United Imaging Healthcare Co., Ltd., CN | QIH |
| May 23, 2023 | K230152 | uMR Omega Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| May 18, 2023 | K230758 | uMR 570 Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Mar 10, 2023 | K223325 | uMI Panorama Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| Feb 16, 2023 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Nov 14, 2022 | K222540 | uPMR 790 Shanghai United Imaging Healthcare Co., Ltd., CN | OUO |
| Oct 27, 2022 | K220332 | uMR Omega with uWS-MR-MRS Shanghai United Imaging Healthcare Co., Ltd., CN | LNH |
| Sep 30, 2022 | K222339 | uDR 380i Pro Shanghai United Imaging Healthcare Co., Ltd., CN | IZL |
| Aug 11, 2021 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
Newest 50 of 85.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 780 Open, Classified |
KPS | K172143 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software Open, Classified |
KPS | K251839 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software Open, Classified |
KPS | K241596 K243538 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software Open, Classified |
KPS | K231572 K241585 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software Open, Classified |
KPS | K223325 K232712 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software Open, Classified |
KPS | K182237 K193241 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT ATLAS Astound with software Open, Classified |
JAK | K203448 K231482 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT ATLAS with software Open, Classified |
JAK | K203448 K231482 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 780 with software Open, Classified |
JAK | K172135 K230162 +2 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 760 with software Open, Classified |
JAK | K172135 K230162 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 550 with software Open, Classified |
JAK | K181414 K200016 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 530 with software Open, Classified |
JAK | K181414 K200016 |
| Apr 7, 2023 | Shanghai United Imaging Healthcare Co., Ltd. Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550
Part Number:
88000657
88000057 Open, Classified |
KPS | K182237 K193241 |
| Oct 13, 2022 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550 Open, Classified |
KPS | K182237 K193241 |
| Aug 2, 2021 | Shanghai United Imaging Healthcare Co., Ltd. uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and t Open, Classified |
KPS | K182237 K193241 |
| Aug 2, 2021 | Shanghai United Imaging Healthcare Co., Ltd. uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment Open, Classified |
KPS | K182237 K193241 |
| Jan 25, 2021 | Shanghai United Imaging Healthcare Co., Ltd. Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric s Terminated |
KPR | K181413 |
| Aug 13, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, res Terminated |
JAK | K182237 |
| Aug 13, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, r Terminated |
KPS | K182938 |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in th Open, Classified |
KPS | K182237 |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Open, Classified |
JAK | K172135 |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Open, Classified |
JAK | K181414 |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Open, Classified |
JAK | K181414 |
| Jul 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | K181414 |
| Jul 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | K181414 |
| Jul 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray tran Open, Classified |
JAK | K172135 |
| Jul 20, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036
Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce Open, Classified |
JAK | K181414 |
| May 8, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uCT 530 Computed Tomography X-Ray System Open, Classified |
JAK | K181414 |
| May 8, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uCT 760 System, Computed Tomography X-ray System Terminated |
JAK | K172135 |
| Mar 26, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to Terminated |
KPS | K182237 |
| Feb 27, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exp Terminated |
KPR | K181413 |
| Aug 26, 2019 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended Terminated |
KPS | K182237 |
| Jul 30, 2019 | Shanghai United Imaging Healthcare Co., Ltd. Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h Terminated |
KPR | K181413 |