uCT

GUDID 06971576831340

Shanghai United Imaging Healthcare Co., Ltd.

Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system
Primary Device ID06971576831340
NIH Device Record Keyff7c54bc-fc35-4b3d-a9a5-da53cf9b14ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameuCT
Version Model NumberuCT ATLAS Astound
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
GS106971576831340 [Primary]

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-08
Device Publish Date2023-02-28

On-Brand Devices [uCT]

06971576831043Computed Tomography X-ray System
06971576831036Computed Tomography X-ray System
06971576831012Computed Tomography X-ray System
06971576831104uCT ATLAS
06971576831340uCT ATLAS Astound
06971576831050Computed Tomography X-ray System
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