Shanghai United Imaging Healthcare Co., Ltd.
Shanghai, CN
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. appears in FDA device records in Shanghai, CN. FDA records list 84 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 21 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 84FDA records hold 84 510(k) clearances for Shanghai United Imaging Healthcare Co., Ltd. between 2018 and 2026. The busiest year on record is 2025, with 17. The most recent is 2026, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 14 |
| 2019 | 9 |
| 2020 | 10 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 10 |
| 2024 | 12 |
| 2025 | 17 |
| 2026 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261427 | uMI Panvivo (uMI Panvivo M) | KPS | Substantially Equivalent | |
| K260113 | uMR Astra | LNH | Substantially Equivalent | |
| K253077 | uOmnispace.MR | QIH | Substantially Equivalent | |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | KPS | Substantially Equivalent | |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | KPS | Substantially Equivalent | |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | |
| K252000 | uDR Arria & uDR Aris | KPR | Substantially Equivalent | |
| K252371 | uMR 680 | LNH | Substantially Equivalent | |
| K250045 | uWS-Angio Pro | LLZ | Substantially Equivalent | |
| K251167 | uDR Aurora CX | KPR | Substantially Equivalent | |
| K250040 | uWS-Angio | LLZ | Substantially Equivalent | |
| K250246 | uMR Jupiter | LNH | Substantially Equivalent | |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | KPS | Substantially Equivalent | |
| K243547 | uMR Ultra | LNH | Substantially Equivalent | |
| K243397 | uMR 680 | LNH | Substantially Equivalent | |
| K243666 | uOmniscan | LLZ | Substantially Equivalent | |
| K243122 | uMR Omega | LNH | Substantially Equivalent | |
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | |
| K242624 | Medical Image Post-processing Software (uOmnispace.CT) | QIH | Substantially Equivalent | |
| K243632 | uWS-Angio Basic | LLZ | Substantially Equivalent | |
| K243376 | uAngio AVIVA CX | OWB | Substantially Equivalent | |
| K241166 | uCT 550 | JAK | Substantially Equivalent | |
| K241079 | uCT 780 | JAK | Substantially Equivalent | |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | KPS | Substantially Equivalent | |
| K241068 | uDR 780i | KPR | Substantially Equivalent | |
| K242515 | uDR 380i Pro | IZL | Substantially Equivalent | |
| K241585 | uMI Panorama | KPS | Substantially Equivalent | |
| K241596 | uMI Panvivo | KPS | Substantially Equivalent | |
| K234154 | uPMR 790 | OUO | Substantially Equivalent | |
| K233209 | uOmnispace.CT | QIH | Substantially Equivalent | |
| K233673 | uMR Jupiter | LNH | Substantially Equivalent | |
| K233186 | uOmnispace.MR | QIH | Substantially Equivalent | |
| K240744 | uMR 680 | LNH | Substantially Equivalent | |
| K240540 | uMR Omega | LNH | Substantially Equivalent | |
| K231762 | uEXPLORER | KPS | Substantially Equivalent | |
| K233176 | uOmnispace.MI | LLZ | Substantially Equivalent | |
| K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | |
| K232712 | uMI Panorama | KPS | Substantially Equivalent | |
| K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | |
| K231572 | uMI Panorama | KPS | Substantially Equivalent | |
| K230039 | uOmnispace | QIH | Substantially Equivalent | |
| K230152 | uMR Omega | LNH | Substantially Equivalent | |
| K230758 | uMR 570 | LNH | Substantially Equivalent | |
| K223325 | uMI Panorama | KPS | Substantially Equivalent | |
| K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | |
| K222540 | uPMR 790 | OUO | Substantially Equivalent | |
| K220332 | uMR Omega with uWS-MR-MRS | LNH | Substantially Equivalent | |
| K222339 | uDR 380i Pro | IZL | Substantially Equivalent | |
| K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | |
| K210001 | HYPER AiR | KPS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011015597 | 3011015597 | SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. | No.2258 Chengbei Rd. Jiading District, Shanghai 201807 CN | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QIHAutomated Radiological Image Processing Software
- MOSCoil, Magnetic Resonance, Specialty
- OWBInterventional Fluoroscopic X-Ray System
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- KPSSystem, Tomography, Computed, Emission
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1353-2023 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 | Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images. | Class II | Open, Classified | |
| Z-0087-2023 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550 | The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient. | Class II | Open, Classified | |
| Z-2594-2021 | 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 treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. | Class II | Open, Classified | |
| Z-2593-2021 | 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 response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. | Class II | Open, Classified | |
| Z-1160-2021 | 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 subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography. | There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient. | Class II | Terminated | |
| Z-0448-2021 | 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 the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation. | Class II | Open, Classified | |
| Z-0447-2021 | 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 data taken at different angles and planes and indicated for the whole body (including head, neck, vascular). | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation. | Class II | Open, Classified | |
| Z-0446-2021 | 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 data taken at different angles and planes and indicated for the whole body (including head, neck, vascular). | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation. | Class II | Open, Classified | |
| Z-0445-2021 | 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 data taken at different angles and planes and indicated for the whole body (including head, neck, vascular). | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation. | Class II | Open, Classified | |
| Z-2800-2020 | 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, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. | 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036) | Class II | Terminated | |
| Z-2799-2020 | 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, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. | 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions. | Class II | Terminated | |
| Z-2705-2020 | 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 transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular). | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Open, Classified | |
| Z-2704-2020 | 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 transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular). | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Open, Classified | |
| Z-2703-2020 | 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 transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular). | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Open, Classified | |
| Z-2641-2020 | 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 cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular). | Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium. | Class II | Open, Classified | |
| Z-2472-2020 | uCT 530 Computed Tomography X-Ray System | Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium. | Class II | Open, Classified | |
| Z-2522-2020 | uCT 760 System, Computed Tomography X-ray System | Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media. | Class II | Terminated | |
| Z-2819-2020 | 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 assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. | In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan. | Class II | Terminated | |
| Z-2521-2020 | 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 exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. | Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation. | Class II | Terminated | |
| Z-1708-2020 | 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 to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. | Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose. | Class II | Terminated | |
| Z-1075-2022 | Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h | X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain