FDA.reportPublic FDA data

uPMR

Primary DI
06971576830084
Brand
uPMR
Company
Shanghai United Imaging Healthcare Co., Ltd.
Model
uPMR 790
Device description
Positron Emission Tomography and Magnetic Resonance Imaging System
Published
2023-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192672000
K222540000
K234154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192672000uPMR 790Shanghai United Imaging Healthcare Co., Ltd.2019-11-20OUO
K222540000uPMR 790Shanghai United Imaging Healthcare Co., Ltd.2022-11-14OUO
K234154000uPMR 790Shanghai United Imaging Healthcare Co., Ltd.2024-05-24OUO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971576830084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971576830084069715768300846971576830084

GMDN Terms#

Term, Definition table
TermDefinition
PET/MRI systemA diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855) 221-1552CustomerSuccess@united-imaging.com

Regulatory Flags#

DUNS number
421271328
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971576832033uMIuMI 7802025-08-03
06971576832170uMIuMI Panorama 352023-03-20
06971576832057uMIuMI 5502020-07-09
06971576832026uMIuMI 5502019-04-03
06971576832040uEXPLORERuEXPLORER2019-03-29
06971576833702uDRuDR Arria2026-03-08
06971576833719uDRuDR Aris2026-03-08
06971576834334uWSuWS-Angio Pro2026-03-08
06971576834341uWSuWS-Angio2026-03-08
06971576834327uWSuWS-Angio Basic2025-08-02
06971576830435uMRuMR Jupiter2024-07-31
06971576830107uMRuMR 6802023-09-21
06971576834150uWSuWS-CT2022-06-19
06971576834013uWSuWS-MR2019-12-10
06971576834020uWSuWS-CT2019-12-10
06971576834037uWSuWS-MI2019-12-10
06971576831340uCTuCT ATLAS Astound2023-02-28
06971576833689uDRuDR Aurora CX2025-11-19
06971576830527uMRuMR Ultra2025-08-03
06971576832163uMIuMI Panorama 282025-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120548Alpine Stirrups, Metric, LeftQfixOUO2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixOUO2026-04-14
04068151020472BIOGRAPH OneSiemens Healthineers AGOUO2026-01-20
00841962120456Alta for HexaPODQfixOUO2026-01-14
00841962120388Lumen AirShuttleQfixOUO2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixOUO2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixOUO2025-10-23
00841439114841ZiFix TraverseMEDTEC, INC.OUO2025-09-12
00841962120340Edge Guide SystemQfixOUO2025-09-11
00841962119467Alpine StirrupsQfixOUO2025-07-09
00841962119474Alpine StirrupsQfixOUO2025-07-09
00841962119481Symphony™QfixOUO2025-07-09
00841962119498AirDrive Trolley™QfixOUO2025-07-09
00841962119528AirShuttle Locating BarQfixOUO2025-07-09
00841962119535AirShuttle Locating BarQfixOUO2025-07-09
00841962119542AirShuttle Transfer HandleQfixOUO2025-07-09
00841962119559InfinityLock™QfixOUO2025-07-09
00841962119573AirShuttle Transfer HandleQfixOUO2025-07-09
00841962119580InfinityLock™QfixOUO2025-07-09
00841962119597AltaQfixOUO2025-07-09
00841962119603AltaQfixOUO2025-07-09
00841962119689Stradivarius™QfixOUO2025-07-09
00841962119696Encompass™QfixOUO2025-07-09
00841962119702Encompass™QfixOUO2025-07-09
00841962119719Encompass™QfixOUO2025-07-09
00841962119726AltaQfixOUO2025-07-09
00841962119733AltaQfixOUO2025-07-09
00841962119740AltaQfixOUO2025-07-09
00841962119757InfinityLock™QfixOUO2025-07-09
00841962119764AltaQfixOUO2025-07-09