Optima
Optima CT680 Expert CT designated medical device
8manufacturers in China registered for this device type
6catalogue numbers in this listing
5510(k) clearances naming this product 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 Hangwei Medical Systems Co., Ltd., China |
|---|---|
| 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) | K192686 |
| Record published | 2019-11-04 |
| Record revised | 2026-04-01 (version 7) |
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 |
|---|---|---|
| CT680 Expert | In distribution | |
| CT580 | In distribution | |
| CT540 N | In distribution | |
| CT520 | In distribution | |
| CT540 | In distribution | |
| Advance | 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 |
|---|---|
| K233749 | 2024-02-22 |
| K192956 | 2020-01-16 |
| K192686 | 2019-10-24 |
| K171013 | 2017-06-05 |
| K123596 | 2013-02-08 |
Recalls Naming This Product
25 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 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 | 11 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 | 11 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 | 8 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 | 5 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 | 10 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 | 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 | 72 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 | 3 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 | 10 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 | 5 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 | 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 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 |
| 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 |
| GE Medical Systems, LLC | 510(k) number | 2014-02-14 | Class II | Software design | GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a | 33 (21 US, 12 OUS) | 2015-04-29 |
| GE Medical Systems, LLC | 510(k) number | 2013-10-09 | Class II | Software design | There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient’s images and another patient’s name in the footer. This is | 272 (29 US; 243 OUS) | 2014-06-19 |
| GE Medical Systems, LLC | 510(k) number | 2011-01-19 | Not classified | Software design | GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomogr | 479 | 2012-07-10 |
| GE Medical Systems, LLC | 510(k) number | 2010-09-03 | Not classified | Software design | GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems. | 68 | 2012-05-15 |
| GE Medical Systems, LLC | 510(k) number | 2010-09-03 | Not classified | Software design | GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems. | 946 | 2012-05-15 |
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.