| Primary Device ID | 06971576832163 | 
| NIH Device Record Key | 782956e5-2be0-4904-8f6b-a96b15189dd0 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | uMI | 
| Version Model Number | uMI Panorama 28 | 
| 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 | false | 
| OTC Over-The-Counter | true | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 06971576832163 [Primary] | 
| KPS | System, Tomography, Computed, Emission | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-08-11 | 
| Device Publish Date | 2025-08-03 | 
| 06971576832026 | Positron Emission Tomography and Computed Tomography System | 
| 06971576832057 | uMI 550 | 
| 06971576832170 | uMI Panorama 35 | 
| 06971576832187 | uMI Panorama GS | 
| 06971576832255 | uMI Panvivo S | 
| 06971576832231 | uMI Panvivo | 
| 06971576832163 | uMI Panorama 28 | 
| 06971576832033 | Positron Emission Tomography and Computed Tomography System |