Revolution
The FDA filing identifies Revolution Ascend as a computed tomography X-ray system. The system reconstructs cross-sectional images from X-ray transmission data collected at different angles…
The FDA filing identifies Revolution Ascend as a computed tomography X-ray system.
The system reconstructs cross-sectional images from X-ray transmission data collected at different angles and planes, including axial, cine, helical, cardiac and gated acquisitions.
Listed Item
Ascend Select Gantry common top asm with UDI
System Configuration
The device description lists a gantry, patient table, operator console, host computer and power distribution unit. It also includes image acquisition and reconstruction hardware and software, system software, documents, accessories and interconnecting cables.
8manufacturers in China registered for this device type
5catalogue numbers in this listing
8510(k) clearances naming this product code
4recalls 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 | GE Healthcare Japan Corporation, Japan |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K203169 |
| Record published | 2020-11-26 |
| Record revised | 2026-01-30 (version 4) |
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 |
|---|---|---|
| Ascend | In distribution | |
| Ascend Select | In distribution | |
| EVO | In distribution | |
| Ascend Elite | In distribution | |
| Ascend Plus | 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 |
|---|---|
| K253686 | 2026-03-23 |
| K233698 | 2024-04-11 |
| K230807 | 2023-04-20 |
| K220961 | 2022-07-29 |
| K213938 | 2022-02-04 |
| K212067 | 2021-09-17 |
| K203169 | 2020-11-20 |
| K193170 | 2019-12-13 |
Recalls Naming This Product
13 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 | 25 units | |
| GE Healthcare (China) Co., Ltd. | 510(k) number | 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 16 units | |
| GE Healthcare (China) Co., Ltd. | UDI-DI | 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 4 units | |
| GE Healthcare (China) Co., Ltd. | 510(k) number | 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 2 units | |
| GE Medical Systems, LLC | UDI-DI | 2022-06-02 | Class II | Error in labeling | As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to ser | 24,843 tables | |
| 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 | 2021-06-14 | Class II | Radiation Control for Health and Safety Act | Improperly loaded software options may result in additional X -ray radiation exposure to the patient. | 3665 | |
| GE Medical Systems, LLC | 510(k) number | 2018-05-24 | Class II | Component change control | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). | 42 units total | 2019-02-08 |
| GE Medical Systems, LLC | 510(k) number | 2018-05-24 | Class II | Component change control | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). | 42 units total | 2019-02-08 |
| GE Healthcare Japan Corporation | 510(k) number | 2018-04-27 | Class II | Employee error | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. | 4,007 devices total (products 1, 2, 3) | 2020-08-21 |
| GE Healthcare Japan Corporation | 510(k) number | 2018-04-27 | Class II | Employee error | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. | 92 OUS only | 2020-08-21 |
| GE Medical Systems, LLC | 510(k) number | 2017-05-19 | Class II | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. | 10,884 | 2018-07-29 |
| GE Medical Systems, LLC | 510(k) number | 2017-05-19 | Class II | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. | 10,884 | 2018-07-29 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2018-04-27 | Class II | Employee error | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. | 4,007 devices total (products 1, 2, 3) | 2020-08-21 |
| 2018-04-27 | Class II | Employee error | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. | 4,007 devices total (products 1, 2, 3) | 2020-08-21 |
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.