uMI
Positron Emission Tomography and Computed Tomography System
8manufacturers in China registered for this device type
1catalogue number
12510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Shanghai United Imaging Healthcare Co., Ltd., China |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Manufacturer |
| 510(k) | K172143 |
| Record published | 2025-08-03 |
| Record revised | 2026-03-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| uMI 780 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253173 | 2026-01-20 |
| K243617 | 2025-05-16 |
| K241166 | 2025-01-14 |
| K241079 | 2025-01-07 |
| K231482 | 2023-11-29 |
| K230162 | 2023-08-01 |
| K223028 | 2023-02-16 |
| K203448 | 2021-08-11 |
| K193073 | 2020-07-06 |
| K200016 | 2020-02-25 |
| K181414 | 2018-08-14 |
| K172135 | 2018-03-02 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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. | 3 units |
Recalls
10 of these are 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 |
|---|---|---|---|---|---|
| 2020-08-05 | 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. | 5 | |
| 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. | 4 | |
| 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. | 5 | |
| 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 |
| 2020-06-20 | Class II | Device Design | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | 5 units | |
| 2020-06-20 | Class II | Device Design | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | 3 | |
| 2020-06-20 | Class II | Device Design | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | 4 | |
| 2020-05-23 | Class II | Software design | Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occa | 3 | |
| 2020-05-08 | Class II | Software design | Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This | 5 units | 2022-01-20 |
| 2020-05-08 | Class II | Software design | Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occ | 4 units |
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.