Somatom Definition Flash
Catalogue number 10430603, 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) | K143416 |
| Record published | 2016-09-24 |
| Record revised | 2023-12-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 50 °C; Handling environment temperature -20 to 50 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Storage environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10430603 | 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
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 | 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 | 2016-11-15 | Class II | Software Design Change | Software update that provides software and firmware bug-fixes to improve system performance | 104 systems | 2018-04-27 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-11-02 | Class II | Software design | Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contra | 7 systems | 2017-11-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-10-19 | Class II | Nonconforming Material/Component | Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts. | 57 systems distributed in USA | 2017-03-13 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-07-13 | Class II | Software in the Use Environment | Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examinatio | 2 systems | 2017-01-24 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2015-08-14 | Class II | Software design | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize im | 113 total | 2016-12-05 |
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.