uMI
The FDA summary identifies uMI Panorama models 28 and 35, including the listed uMI Panorama 35. The system combines PET and CT imaging; its PET component measures radiopharmaceutical…
The FDA summary identifies uMI Panorama models 28 and 35, including the listed uMI Panorama 35.
The system combines PET and CT imaging; its PET component measures radiopharmaceutical distribution while CT provides anatomical imaging.
Listed Item
Positron Emission Tomography and Computed Tomography System, mobile configuration
System Components
The filing specifies a 280 or 350-millimeter axial field of view for PET paired with a 160-slice CT system. It lists a patient table, power-distribution unit and control and reconstruction system, including a host, monitor and reconstruction computer.
4manufacturers in China registered for this device type
7catalogue numbers in this listing
18510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Neusoft Positron Medical Systems Co., Ltd. | Shen Yang | Liaoning | Manufacturer | 1 |
Record
| Listed by | Shanghai United Imaging Healthcare Co., Ltd., China |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Manufacturer |
| 510(k) | K223325 |
| Record published | 2023-03-20 |
| Record revised | 2026-03-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| uMI Panorama 35 | In distribution | |
| uMI Panvivo S | In distribution | |
| uMI 550 | In distribution | |
| uMI Panvivo | In distribution | |
| uMI Panorama GS | In distribution | |
| uMI Panorama 28 | In distribution | |
| uMI 550 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeuroQ | Syntermed, Inc. | 11 |
| Emory Cardiac Toolbox | Syntermed, Inc. | 10 |
| Discovery | GE Medical Systems, L.L.C. | 7 |
| Brightonix | Brightonix Imaging Inc. | 6 |
| UltraSPECT | Ultraspect USA, LLC | 5 |
| Discovery | G E Medical Systems Israel Ltd. | 5 |
| Veriton CT | Spectrum Dynamics Medical Ltd. | 5 |
| Cardius 2 | Digirad Corp. | 4 |
| Encompass™ SRS Fibreplast™ System | Qfix | 4 |
| Veriton NM | Spectrum Dynamics Medical Ltd. | 3 |
| Cedars-Sinai Cardiac Suite | Cedars Sinai Medical Center | 3 |
| Affinity | Hermes Medical Solutions, AB | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261427 | 2026-07-28 |
| K260524 | 2026-04-03 |
| K253564 | 2026-02-13 |
| K251839 | 2025-07-17 |
| K243538 | 2024-12-12 |
| K241585 | 2024-08-30 |
| K241596 | 2024-08-15 |
| K231762 | 2024-01-18 |
| K232712 | 2023-10-03 |
| K231572 | 2023-07-26 |
| K223325 | 2023-03-10 |
| K210001 | 2021-04-30 |
| K210418 | 2021-04-09 |
| K193210 | 2020-08-04 |
| K193241 | 2020-01-26 |
| K182938 | 2018-12-18 |
| K182237 | 2018-10-12 |
| K172143 | 2018-04-13 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| UIH Technologies, LLC | 510(k) number | 2025-09-12 | Class II | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. | 95 units | |
| UIH Technologies, LLC | 510(k) number | 2025-09-12 | Class II | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. | 4 unit | |
| Shanghai United Imaging Healthcare Co., Ltd. | 510(k) number | 2023-03-01 | Class II | Software design | Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images. | 47 systems (U.S. only) | |
| Shanghai United Imaging Healthcare Co., Ltd. | 510(k) number | 2022-05-30 | Class II | Device Design | The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition ca | 32 | |
| Shanghai United Imaging Healthcare Co., Ltd. | 510(k) number | 2021-08-02 | Class II | Device Design | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. | 23 systems | |
| Shanghai United Imaging Healthcare Co., Ltd. | 510(k) number | 2021-08-02 | Class II | Device Design | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. | 1 system | |
| Shanghai United Imaging Healthcare Co., Ltd. | 510(k) number | 2020-08-05 | Class II | Software design | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation. | 9 | |
| Shanghai United Imaging Healthcare Co., Ltd. | 510(k) number | 2020-07-16 | Class II | Device Design | 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of myla | 4 units | 2022-07-07 |
| Shanghai United Imaging Healthcare Co., Ltd. | 510(k) number | 2020-03-26 | Class II | Software design | In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, t | 3 | 2023-08-02 |
| Shanghai United Imaging Healthcare Co., Ltd. | 510(k) number | 2019-08-26 | Class II | Software design | Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional | 2 units | 2022-05-18 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-07-16 | Class II | Device Design | 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip i | 1 unit distributed to Texas | 2022-07-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.