Somatom Go.top
Catalogue number 11061648, listed by Siemens Shanghai, Medical Equipment Ltd., China, 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
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 | Siemens Shanghai, Medical Equipment Ltd., China |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K173632 |
| Record published | 2018-05-26 |
| Record revised | 2025-11-27 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Handling environment temperature -20 to 50 °C; Storage environment temperature -20 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11061648 | 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
18 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-03-07 | Class II | Software design | Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient | 547 units US | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-03-03 | Class II | Software design | SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. S | 190 units US | 2023-12-28 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-09-24 | Class II | Software design | SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures | 14 US | 2024-07-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 0 | 2020-12-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 18 units | 2020-12-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 3 units | 2020-12-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 10 units | 2020-12-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 0 | 2020-12-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 12 units | 2020-12-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-31 | Class II | Nonconforming Material/Component | The injector holder could potentially fall off together with the injector and the storage box. | 0 | 2020-12-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-06-04 | Class II | Software design | The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan. | 69 | 2023-03-29 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-06-04 | Class II | Software design | The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan. | 69 | 2023-03-29 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-06-04 | Class II | Software design | The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan. | 69 | 2023-03-29 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-06-04 | Class II | Software design | The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan. | 69 | 2023-03-29 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-05-28 | Class II | Software design | The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans. | 9 | 2023-03-31 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-05-28 | Class II | Software design | The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans. | 53 | 2023-03-31 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-05-28 | Class II | Software design | The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans. | 24 | 2023-03-31 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-05-28 | Class II | Software design | The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans. | 30 | 2023-03-31 |
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.