uCT
The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray…
The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
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 | UIH Technologies, LLC, United States |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2020-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| uCT 530 | In distribution | |
| uCT 780 | In distribution | |
| uCT 760 | In distribution | |
| uCT 550 | 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
Recalls
9 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 |
|---|---|---|---|---|
| 2025-09-12 | Class II | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. | 2 units |
| 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 |
| 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 |
| 2025-09-12 | Class II | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. | 2 UNITS |
| 2025-09-12 | Class II | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. | 11 units |
| 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 |
| 2025-09-12 | Class II | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. | 8 units |
| 2025-09-12 | Class II | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. | 22 units |
| 2025-09-12 | Class II | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. | 2 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.