Spectral CT
Catalogue number Spectral CT, listed by Philips Medical Systems Nederland B.V., Netherlands, under System, X-Ray, Tomography, Computed. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
1recall
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 | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2021-03-11 |
| Record revised | 2026-07-27 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Spectral CT | 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 |
|---|---|
| K260169 | 2026-03-05 |
| K250648 | 2025-06-27 |
| K212875 | 2022-05-13 |
| K210760 | 2022-01-14 |
| K203020 | 2021-02-26 |
| K203216 | 2020-11-25 |
| K193454 | 2020-01-24 |
| K182716 | 2019-05-29 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2026-01-07 | Class II | Process change control | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to sp | 283 units | |
| Philips North America LLC | UDI-DI | 2025-05-29 | Class II | Under Investigation by firm | Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance. | 370 units | |
| Philips North America LLC | UDI-DI | 2024-11-16 | Class II | Under Investigation by firm | Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lea | 301 units | |
| Philips North America LLC | UDI-DI | 2024-03-29 | Class II | Under Investigation by firm | Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment. | 12 units | |
| Philips Medical Systems Technologies Ltd | UDI-DI | 2023-12-13 | Class II | Under Investigation by firm | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. | US: 33, OUS 177 | |
| Philips North America LLC | UDI-DI | 2023-11-30 | Class II | Software design | Multiple software issues that affect device functionality. | 197 units | |
| Philips North America LLC | UDI-DI | 2023-03-17 | Class II | Under Investigation by firm | Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligamen | 92 units | |
| Philips North America LLC | UDI-DI | 2021-06-08 | Class II | Software design | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient. | 1 unit | 2023-08-10 |
| Philips North America LLC | UDI-DI | 2021-05-01 | Class II | Device Design | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attach | 1,301 Monitor Bracket Assemblies total |
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 |
|---|---|---|---|---|
| 2025-02-28 | Class II | Under Investigation by firm | Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement. | 1 unit |
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.