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 |
Customer Support Contacts
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com | |
| Phone | +1(855) 221-1552 |
| CustomerSuccess@united-imaging.com |
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.
| 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 |
Trademark Results [uEXPLORER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UEXPLORER 87695852 not registered Live/Pending |
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. 2017-11-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.