uWS

GUDID 06971576834150

Shanghai United Imaging Healthcare Co., Ltd.

Radiology DICOM image processing application software

• Primary Device ID: 06971576834150
• NIH Device Record Key: cd334e03-95d3-4ee5-af9b-9beaf267cfcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uWS
• Version Model Number: uWS-CT
• 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	06971576834150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203448

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-19

On-Brand Devices [uWS]

• 06971576834037: PET/CT Image Post-Processing Software
• 06971576834020: CT Image Post-Processing Software
• 06971576834013: MR Image Post-Processing Software
• 06971576834150: uWS-CT
• 06971576834143: uWS-MR