Artis Zee Biplane MN
Catalogue number 10094143, 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) | K122644 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Handling environment humidity 20 to 75 % RH; Storage environment temperature -20 to 70 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10094143 | 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
12 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 | 2018-05-25 | Class II | Process control | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure | 3 US | 2019-05-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-01 | Class II | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, | 68 | 2019-05-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-01 | Class II | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, | 2 | 2019-05-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-01 | Class II | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, | 73 | 2019-05-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-01 | Class II | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, | 14 | 2019-05-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-01 | Class II | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, | 1 | 2019-05-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-01 | Class II | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, | 1 | 2019-05-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-05-01 | Class II | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, | 56 | 2019-05-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-09-28 | Class II | Device Design | The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radia | 510 | 2020-03-09 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-12-08 | Class II | Software in the Use Environment | Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: – In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detectio | 1,500 distributed Worldwide | 2019-04-09 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-11-01 | Class II | Software in the Use Environment | The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times. | 4,657 systems Worldwide | 2017-06-21 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2015-05-22 | Class II | Software design | There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported. | 475 | 2016-12-13 |
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.