uDR

GUDID 06971576833061

Digital Medical X-ray Imaging System

Shanghai United Imaging Healthcare Co., Ltd.

Stationary basic diagnostic x-ray system, digital
Primary Device ID06971576833061
NIH Device Record Key1c033e3f-dce5-4de1-a21c-8dea3ddfc7f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameuDR
Version Model NumberuDR 780i
Company DUNS421271328
Company NameShanghai United Imaging Healthcare Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971576833061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-16
Device Publish Date2023-10-08

On-Brand Devices [uDR]

06971576833023Digital Medical X-ray Imaging System
06971576833276uDR 380i Pro
06971576833061Digital Medical X-ray Imaging System

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