uCT

GUDID 06971576831036

Computed Tomography X-ray System

Shanghai United Imaging Healthcare Co., Ltd.

Full-body CT system

• Primary Device ID: 06971576831036
• NIH Device Record Key: 70e93581-47eb-4644-81d6-2b7be6f1caae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uCT
• Version Model Number: uCT 550
• Company DUNS: 421271328
• Company Name: Shanghai United Imaging Healthcare Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971576831036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181414

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-24
• Device Publish Date: 2019-03-26

On-Brand Devices [uCT]

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