Revolution CT
Revolution CT ES with Apex edition - Designated System Medical Device
8manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | GE Medical Systems, L.L.C. |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| 510(k) | K191777 |
| Record published | 2022-12-16 |
| Record revised | 2026-02-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ES with Apex edition | In distribution | |
| with Apex edition | 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 Naming This Product
19 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2026-03-26 | Class II | Software design | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution C | 38 units | |
| GE Medical Systems, LLC | 510(k) number | 2026-03-26 | Class II | Software design | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution C | 11 units | |
| GE Medical Systems, LLC | 510(k) number | 2026-03-26 | Class II | Software design | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution C | 10 units | |
| GE Medical Systems, LLC | 510(k) number | 2026-03-26 | Class II | Software design | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution C | 24 units | |
| GE Medical Systems, LLC | 510(k) number | 2025-02-18 | Class II | Process change control | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near | 56 units | |
| GE Medical Systems, LLC | 510(k) number | 2025-02-18 | Class II | Process change control | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near | 4 units | |
| GE Medical Systems, LLC | UDI-DI | 2025-02-18 | Class II | Process change control | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near | 105 units | |
| GE Medical Systems, LLC | 510(k) number | 2025-02-18 | Class II | Process change control | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near | 21 units | |
| GE Medical Systems, LLC | 510(k) number | 2021-06-30 | Class II | Radiation Control for Health and Safety Act | The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will sh | 105 in total | |
| GE Medical Systems, LLC | 510(k) number | 2021-06-30 | Class II | Radiation Control for Health and Safety Act | The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high. | 273 (51 US, 222 OUS) in total | |
| GE Medical Systems, LLC | 510(k) number | 2021-06-30 | Class II | Radiation Control for Health and Safety Act | The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high. | 273 (51 US; 222 OUS) in total | |
| GE Medical Systems, LLC | 510(k) number | 2021-06-30 | Class II | Process design | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition. | ||
| GE Medical Systems, LLC | 510(k) number | 2021-06-30 | Class II | Process design | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition. | ||
| GE Medical Systems, LLC | 510(k) number | 2021-03-19 | Class II | Radiation Control for Health and Safety Act | GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or sm | 197 (US = 40; OUS = 157) | |
| GE Medical Systems, LLC | 510(k) number | 2020-12-17 | Class II | Process change control | GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws | 96 units | 2023-01-09 |
| GE Medical Systems, LLC | 510(k) number | 2020-12-17 | Class II | Process change control | GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws | 1115 units | 2023-01-09 |
| GE Medical Systems, LLC | 510(k) number | 2020-11-23 | Class II | Software in the Use Environment | A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling | 2 units | 2023-08-29 |
| GE Medical Systems, LLC | 510(k) number | 2020-11-23 | Class II | Software in the Use Environment | A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling | 3 units | 2023-08-29 |
| GE Medical Systems, LLC | 510(k) number | 2020-09-21 | Class II | Device Design | There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings. | 64 devices | 2022-12-28 |
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.