uPMR

GUDID 06971576830084

Shanghai United Imaging Healthcare Co., Ltd.

PET/MRI system

• Primary Device ID: 06971576830084
• NIH Device Record Key: 3a98b6e6-f15a-43f8-b20a-c125d669a690
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uPMR
• Version Model Number: uPMR 790
• 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

Customer Support Contacts

• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com
• Phone: +1(855) 221-1552
• Email: CustomerSuccess@united-imaging.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971576830084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192672

FDA Product Code

• OUO: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

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: 2023-10-16
• Device Publish Date: 2023-10-08

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