uMR

GUDID 06971576830015

Magnetic Resonance Imaging System

Shanghai United Imaging Healthcare Co., Ltd.

Full-body MRI system, superconducting magnet
Primary Device ID06971576830015
NIH Device Record Keycb986259-bbb9-4a8b-be7a-67b2e0530e05
Commercial Distribution StatusIn Commercial Distribution
Brand NameuMR
Version Model NumberuMR 570
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
GS106971576830015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-27
Device Publish Date2018-11-05

On-Brand Devices [uMR]

06971576830015Magnetic Resonance Imaging System
06971576830114uMR Omega
06971576830107uMR 680

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