System Somatom Confidence
Catalogue number 10590100, listed by Siemens Healthcare Limited, Canada, 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
14510(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 | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K162302 |
| Record published | 2016-12-21 |
| Record revised | 2023-12-14 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature -20 to 50 °C; Handling environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 50 °C; Storage environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10590100 | 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 |
|---|---|
| K233753 | 2024-03-21 |
| K213713 | 2022-08-11 |
| K170221 | 2017-04-21 |
| K110366 | 2011-04-12 |
| K071310 | 2007-06-08 |
| K063507 | 2006-11-30 |
| K053024 | 2005-11-04 |
| K050867 | 2005-04-14 |
| K991600 | 1999-06-09 |
| K984634 | 1999-03-12 |
| K982536 | 1998-11-24 |
| K941546 | 1994-09-20 |
| K790975 | 1979-07-30 |
| K790342 | 1979-03-22 |
Recalls Naming This Product
14 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 | 2021-11-19 | Class II | Software Design Change | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | 108 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-11-19 | Class II | Software Design Change | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | 794 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-11-19 | Class II | Software Design Change | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | 80 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-11-19 | Class II | Software Design Change | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 232 units | 2024-01-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 665 units | 2024-01-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 298 units | 2024-01-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 121 unit | 2024-01-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 75 units | 2024-01-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 104 units | 2024-01-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-08-30 | Class II | Software design | software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the ne | 64 units | 2024-01-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-25 | Class II | Software design | SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in d | 2867 units worldwide (OUS); 1464 units US | 2022-12-29 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-03 | Class II | Software design | Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. | 2024-05-10 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-07-03 | Class II | Software design | Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. | 2024-05-10 |
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.