uWS

GUDID 06971576834327

Shanghai United Imaging Healthcare Co., Ltd.

Angiographic x-ray system application software
Primary Device ID06971576834327
NIH Device Record Key17a93eaa-2dfb-4cae-a848-3114598b1c5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameuWS
Version Model NumberuWS-Angio Basic
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
GS106971576834327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-11
Device Publish Date2025-08-02

On-Brand Devices [uWS]

06971576834037PET/CT Image Post-Processing Software
06971576834020CT Image Post-Processing Software
06971576834013MR Image Post-Processing Software
06971576834150uWS-CT
06971576834143uWS-MR
06971576834327uWS-Angio Basic

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