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Shanghai United Imaging Healthcare Co.,ltd.: FDA-registered device maker in Shanghai, China, 66 510(k) clearances

Name: Shanghai United Imaging Healthcare Co.,ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai United Imaging Healthcare Co.,ltd. is registered with the FDA (registration 3011015597) in Shanghai, China. It lists 12 device types. The FDA files 66 510(k) clearances under its listings, the newest dated July 28, 2026. 15 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3011015597
Address: No.2258 Chengbei Rd. Jiading District, Shanghai, China, 201807
Owner or operator: Shanghai United Imaging Healthcare Co.,Ltd. (10057992)
Roles: Manufacturer
First device listed: September 4, 2018
Registered through: 2027
Brand names listed: HYPER AiR, HYPER DLR, HYPER Focus, uAngio AVIVA CX, uCT 530, uCT 550, uCT 760, uCT 780 and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Coil, Magnetic Resonance, Specialty	MOS	2	Manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	OUO	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 28, 2026	K261427	uMI Panvivo (uMI Panvivo M)	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
November 26, 2025	K252000	uDR Arria & uDR Aris	KPR	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
September 25, 2025	K252371	uMR 680	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
September 24, 2025	K250045	uWS-Angio Pro	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
September 19, 2025	K251167	uDR Aurora CX	KPR	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
September 12, 2025	K250040	uWS-Angio	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
August 5, 2025	K250246	uMR Jupiter	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
July 17, 2025	K251839	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
July 17, 2025	K243547	uMR Ultra	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
July 16, 2025	K243397	uMR 680	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
June 17, 2025	K243666	uOmniscan	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
May 21, 2025	K243122	uMR Omega	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
May 16, 2025	K243617	uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
May 14, 2025	K242624	Medical Image Post-processing Software (uOmnispace.CT)	QIH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
May 12, 2025	K243632	uWS-Angio Basic	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
April 28, 2025	K243376	uAngio AVIVA CX	OWB	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
January 14, 2025	K241166	uCT 550	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
January 7, 2025	K241079	uCT 780	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
December 12, 2024	K243538	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
November 1, 2024	K241068	uDR 780i	KPR	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
October 10, 2024	K242515	uDR 380i Pro	IZL	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
August 30, 2024	K241585	uMI Panorama	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
August 15, 2024	K241596	uMI Panvivo	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
May 24, 2024	K234154	uPMR 790	OUO	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
May 17, 2024	K233209	uOmnispace.CT	QIH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
April 26, 2024	K233673	uMR Jupiter	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
April 17, 2024	K233186	uOmnispace.MR	QIH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
April 10, 2024	K240744	uMR 680	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
March 22, 2024	K240540	uMR Omega	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
January 18, 2024	K231762	uEXPLORER	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
December 20, 2023	K233176	uOmnispace.MI	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
November 29, 2023	K231482	uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
October 3, 2023	K232712	uMI Panorama	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
August 1, 2023	K230162	uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
July 26, 2023	K231572	uMI Panorama	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
July 20, 2023	K230039	uOmnispace	QIH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
May 23, 2023	K230152	uMR Omega	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
March 10, 2023	K223325	uMI Panorama	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
February 16, 2023	K223028	uCT ATLAS Astound with uWS-CT-Dual Energy Analysis	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
February 16, 2023	K222755	uMR 680	LNH	Substantially Equivalent	Shanghai United Imaging Intelligence Co., Ltd.	accessdata.fda.gov
November 14, 2022	K222540	uPMR 790	OUO	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
October 27, 2022	K220332	uMR Omega with uWS-MR-MRS	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
September 30, 2022	K222339	uDR 380i Pro	IZL	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
August 11, 2021	K203448	uCT ATLAS with uWS-CT-Dual Energy Analysis	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
April 30, 2021	K210001	HYPER AiR	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
April 9, 2021	K210418	HYPER Focus	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
August 4, 2020	K193210	HYPER DLR	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
June 11, 2020	K192630	uWS-MI	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
June 1, 2020	K192601	uWS-MR	QIH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
March 27, 2020	K193200	uMR Omega	LNH	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
February 25, 2020	K200016	uCT 530, uCT 550	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
January 26, 2020	K193241	Emission Computed Tomography System	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
November 20, 2019	K192672	uPMR 790	OUO	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
September 12, 2019	K192293	uDR 592h, uDR 596i	KPR	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
June 24, 2019	K183170	uWS-CT	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
March 22, 2019	K183164	uWS-MR	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
December 18, 2018	K182938	Emission Computed Tomography System	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
November 7, 2018	K173001	uWS-CT	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
November 7, 2018	K172999	uWS-MR	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
October 12, 2018	K182237	uMI 550 PET/CT System	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
August 14, 2018	K181414	uCT 530, uCT 550	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
June 27, 2018	K181413	uDR 592h, uDR 596i	KPR	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
April 13, 2018	K172143	uMI 780 PET/CT System	KPS	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
April 5, 2018	K172998	uWS-MI	LLZ	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
March 2, 2018	K172135	uCT Computed Tomography X-ray System	JAK	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov
January 26, 2018	K173953	uDR 780i	KPR	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 11, 2026	99731	Class II	Ongoing	Computed Tomography X-ray System, Model: uCT 530 with software	Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.	accessdata.fda.gov
March 1, 2023	91870	Class II	Ongoing	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.	accessdata.fda.gov
May 30, 2022	90888	Class II	Ongoing	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	accessdata.fda.gov
August 2, 2021	88521	Class II	Ongoing	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	The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.	accessdata.fda.gov
January 25, 2021	87289	Class II	Terminated	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 d	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.	accessdata.fda.gov
August 5, 2020	86269	Class II	Ongoing	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 differen	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.	accessdata.fda.gov
July 16, 2020	85948	Class II	Terminated	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	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.	accessdata.fda.gov
June 20, 2020	85868	Class II	Ongoing	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 a	The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.	accessdata.fda.gov
May 23, 2020	85771	Class II	Ongoing	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 image	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 additiona	accessdata.fda.gov
May 8, 2020	85809	Class II	Ongoing	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 additiona	accessdata.fda.gov
May 8, 2020	85804	Class II	Terminated	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 possi	accessdata.fda.gov
March 26, 2020	85453	Class II	Terminated	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 detect	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	accessdata.fda.gov
February 27, 2020	85196	Class II	Terminated	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,	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 inform	accessdata.fda.gov
August 26, 2019	85340	Class II	Terminated	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 qu	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.	accessdata.fda.gov
July 30, 2019	90104	Class II	Terminated	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.	accessdata.fda.gov

Compare with other makers

Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.