uEXPLORER

GUDID 06971576832040

Positron Emission Tomography and Computed Tomography System

Shanghai United Imaging Healthcare Co., Ltd.

PET/CT system

• Primary Device ID: 06971576832040
• NIH Device Record Key: 7a0ad3ee-2f90-4625-9b5a-82f9f181cf26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uEXPLORER
• Version Model Number: uEXPLORER
• 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	06971576832040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182938

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-29

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

• 06971576830435 - uMR: 2024-08-08
• 06971576830084 - uPMR: 2023-10-16
• 06971576831050 - uCT: 2023-10-16 Computed Tomography X-ray System
• 06971576833061 - uDR: 2023-10-16 Digital Medical X-ray Imaging System
• 06971576830107 - uMR: 2023-09-29
• 06971576832187 - uMI: 2023-09-29
• 06971576832170 - uMI: 2023-03-28
• 06971576831340 - uCT: 2023-03-08