FDA.reportPublic FDA data

uDR

Primary DI
06971576833023
Brand
uDR
Company
Shanghai United Imaging Healthcare Co., Ltd.
Model
uDR 596i
Device description
Digital Medical X-ray Imaging System
Published
2018-12-28
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
KPRSystem, X-Ray, Stationary
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181413000
K192293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181413000uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.2018-06-27KPR
K192293000uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.2019-09-12KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971576833023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971576833023069715768330236971576833023

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

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
08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
08800017000107DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000114DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000121DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000138DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08683161912041GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08683161912058GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340277Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
08056600520051Nical Flat PanelNICAL SPAMQB2023-10-09
08057737122217Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2023-08-29