Toshiba Scanner
This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SCANNER. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS…
This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SCANNER. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now CT SCANNER.
8manufacturers in China registered for this device type
10catalogue numbers in this listing
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 | Canon Inc., Japan |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K151833 |
| Record published | 2018-03-02 |
| Record revised | 2026-03-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TSX-035A | In distribution | |
| TSX-201A | In distribution | |
| TSX-036A | In distribution | |
| TSX-301C | In distribution | |
| TSX-302A | In distribution | |
| TSX-305A | In distribution | |
| TSX-101A | In distribution | |
| TSX-303A | In distribution | |
| TSX-303B | In distribution | |
| TSX-301A | 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 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
| Imactis® | Imactis, SAS | 6 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
Recalls Naming This Product
29 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 |
|---|---|---|---|---|---|---|---|
| Canon Medical System, USA, Inc. | 510(k) number | 2020-11-09 | Class II | Software design | A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning | 60 units | 2022-12-16 |
| Canon Medical System, USA, Inc. | 510(k) number | 2019-03-25 | Class II | Software design | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would oc | 6 devices | |
| Canon Medical System, USA, Inc. | 510(k) number | 2019-03-25 | Class II | Software design | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would oc | 2 devices | |
| Canon Medical System, USA, Inc. | 510(k) number | 2019-03-25 | Class II | Software design | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would oc | 1 device | |
| Canon Medical System, USA, Inc. | 510(k) number | 2019-03-25 | Class II | Software design | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would oc | 10 devices | |
| Canon Medical System, USA, Inc. | 510(k) number | 2019-03-25 | Class II | Software design | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would oc | 10 devices | |
| Canon Medical System, USA, Inc. | 510(k) number | 2019-03-25 | Class II | Software design | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would oc | 35 devices | |
| Toshiba American Medical Systems Inc | 510(k) number | 2016-10-25 | Class II | Device Design | Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation. | 291 units | 2017-08-19 |
| Toshiba American Medical Systems Inc | 510(k) number | 2016-04-12 | Class II | Device Design | Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry. | 1 unit | 2016-05-19 |
| Toshiba American Medical Systems Inc | 510(k) number | 2015-05-08 | Class II | Radiation Control for Health and Safety Act | If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | 459 | 2016-10-26 |
| Toshiba American Medical Systems Inc | 510(k) number | 2015-05-08 | Class II | Radiation Control for Health and Safety Act | If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | 459 | 2016-10-26 |
| Toshiba American Medical Systems Inc | 510(k) number | 2015-05-08 | Class II | Radiation Control for Health and Safety Act | If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | 459 | 2016-10-26 |
| Toshiba American Medical Systems Inc | 510(k) number | 2015-05-08 | Class II | Radiation Control for Health and Safety Act | If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | 459 | 2016-10-26 |
| Toshiba American Medical Systems Inc | 510(k) number | 2015-05-08 | Class II | Radiation Control for Health and Safety Act | If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. | 459 | 2016-10-26 |
| Toshiba American Medical Systems Inc | 510(k) number | 2014-11-05 | Class II | Software design | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curv | 1 unit within the U.S. only | 2015-10-09 |
| Toshiba American Medical Systems Inc | 510(k) number | 2014-11-05 | Class II | Software design | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curv | 2 units within the U.S. only | 2015-10-09 |
| Toshiba American Medical Systems Inc | 510(k) number | 2013-12-11 | Class II | Other | Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed. | 8 units | 2014-10-16 |
| Toshiba American Medical Systems Inc | 510(k) number | 2013-10-01 | Class II | Software design | Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used | 338 units | 2015-03-03 |
| Toshiba American Medical Systems Inc | 510(k) number | 2012-11-14 | Class II | Process design | Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output | 1 unit | 2013-04-08 |
| Toshiba American Medical Systems Inc | 510(k) number | 2011-06-22 | Not classified | Software design | Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, To | 155 units total | 2014-08-11 |
| Toshiba American Medical Systems Inc | 510(k) number | 2010-12-08 | Not classified | Software design | There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform. | 528 units | 2013-03-18 |
| Toshiba American Medical Systems Inc | 510(k) number | 2010-04-09 | Not classified | Software design | The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed). | 35 | 2012-08-17 |
| Toshiba American Medical Systems Inc | 510(k) number | 2009-07-13 | Class II | Software design | 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch pos | 24 Systems | 2012-09-04 |
| Toshiba American Medical Systems Inc | 510(k) number | 2009-02-03 | Not classified | Software design | ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB. | 16 | 2011-09-02 |
| Toshiba American Medical Systems Inc | 510(k) number | 2009-01-08 | Not classified | Component design/selection | Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large vol | 94 | 2012-06-01 |
| Toshiba American Medical Systems Inc | 510(k) number | 2009-01-08 | Not classified | Component design/selection | Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large vol | 397 | 2012-06-01 |
| Toshiba American Medical Systems Inc | 510(k) number | 2009-01-08 | Not classified | Component design/selection | Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large vol | 9 | 2012-06-01 |
| Toshiba American Medical Systems Inc | 510(k) number | 2009-01-08 | Not classified | Component design/selection | Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large vol | 47 | 2012-06-01 |
| Toshiba American Medical Systems Inc | 510(k) number | 2008-05-13 | Class II | Software design | The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function. | 3 units | 2012-09-27 |
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.