uOmniscan

GUDID 06971576834358

Shanghai United Imaging Healthcare Co., Ltd.

Radiology DICOM image processing application software

• Primary Device ID: 06971576834358
• NIH Device Record Key: 469f398c-08c8-4646-b0ff-3282cc2527a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uOmniscan
• Version Model Number: uOmniscan
• 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: false
• 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	06971576834358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243666

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: 2025-08-11
• Device Publish Date: 2025-08-03

Devices Manufactured by Shanghai United Imaging Healthcare Co., Ltd.

• 06971576830527 - uMR: 2025-08-11 Magnetic Resonance Imaging System
• 06971576832033 - uMI: 2025-08-11 Positron Emission Tomography and Computed Tomography System
• 06971576832163 - uMI: 2025-08-11
• 06971576832231 - uMI: 2025-08-11
• 06971576832255 - uMI: 2025-08-11
• 06971576833498 - uAngio: 2025-08-11
• 06971576834204 - uOmnispace: 2025-08-11
• 06971576834228 - uOmnispace: 2025-08-11