Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011015597

FEI Number

3011015597

Entity Name

SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.

City/State/Country

Shanghai, CN

Establishment Address

No.2258 Chengbei Rd. Jiading District, Shanghai 201807, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai United Imaging Healthcare Co.,Ltd. (Owner Number: 10057992)

Owner / Operator Contact Address

No.2258 Chengbei Rd. Jiading District, Shanghai, CN-SH 201807, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250045

PMA Number

N/A

All Registered Proprietary Names

uWS-CT uDR Aurora CX uWS-MR uDR 380i Pro uCT 530 uCT 550 uMR Omega uPMR 790 uDR 780i uOmniscan uEXPLORER uEXPLORER uMI Panvivo uWS-Angio uPMR 790 uCT ATLAS uWS-CT uOmnispace uMI Panorama 35 uMI Panorama 28 uMR 680 HYPER AiR uMR Omega uMR Omega uMR 680 uMI Panvivo uMI Panvivo S uCT 780 uMI Panorama GS uDR 596i uDR 592h uDR 380i Pro uMI Panorama GS uMR Ultra uOmnispace.CT uMI 550 uWS-MI uMR 680 uMI 780 HYPER DLR uMI 550 uCT 550 uCT 530 HYPER Focus uDR 780i uMR Omega uWS-Angio Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-11-11
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2025-11-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-12-10
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2023-02-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-09-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-07-25
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-07-25
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	Class 2	892.1200	2020-02-12
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2025-06-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-07-25
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-12-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-12-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-09-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-09-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-10-16
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-10-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-12-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-06-03
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	Class 2	892.1200	2024-06-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-12-06
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-12-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-03-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-03-14
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-12-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-12-03
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-12-03
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2022-11-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-05-31
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-03-28
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-09-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-09-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-06-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-06-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-06-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-09-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-09-06
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-09-15
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-09-15
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2025-06-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-09-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-09-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-07-25
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-06-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-02-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-02-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-06-29
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-02-23
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-09-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-09-04
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-08-10
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-11-02
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-11-02
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-03-05
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2022-11-04
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2018-09-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-09-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-09-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-12-03

Official Correspondent

Shumei WANG

US Agent Details

Weiguo ZHANG Email: weiguo.zhang@united-imaging.com Phone: (650) 8886887

Related Public Records

Same Entity

Shanghai United Imaging Healthcare Co.,Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011015597. Last updated year: 2026. Please use registration number 3011015597 when referencing this establishment in official correspondence.