uMR

GUDID 06971576830114

Shanghai United Imaging Healthcare Co., Ltd.

Full-body MRI system, superconducting magnet

• Primary Device ID: 06971576830114
• NIH Device Record Key: 4e94abec-3e2c-43fe-9165-5a4076c1a121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uMR
• Version Model Number: uMR Omega
• 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	06971576830114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193200

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [uMR]

• 06971576830015: Magnetic Resonance Imaging System
• 06971576830114: uMR Omega
• 06971576830107: uMR 680
• 06971576830435: uMR Jupiter
• 06971576830527: Magnetic Resonance Imaging System