Artis Icono Biplane
Catalogue number 11327600, 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) | K190768 |
| Record published | 2020-01-10 |
| Record revised | 2026-05-06 (version 8) |
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 atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 75 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11327600 | 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
23 recalls name this product by its own identifiers, the UDI on its label or 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 | 2026-05-20 | Class II | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | 85 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-05-20 | Class II | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | 119 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-05-20 | Class II | Software design | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | 30 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-03-12 | Class II | Radiation Control for Health and Safety Act | During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient | 73 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-03-10 | Class II | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with | U.S. 758, OUS 2077 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-03-09 | Class II | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2026-03-09 | Class II | Radiation Control for Health and Safety Act | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-08-12 | Class II | Software design | Limited system movements after startup. | 20 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-05-15 | Class II | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-05-15 | Class II | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. | ||
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-05-15 | Class II | Radiation Control for Health and Safety Act | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose. | ||
| Siemens Healthineers AG | 510(k) number | 2024-06-26 | Class II | Software design | A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed wit | 201 units in total | |
| Siemens Healthineers AG | 510(k) number | 2024-06-26 | Class II | Software design | A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed wit | 201 units in total | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2023-06-19 | Class II | Process control | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator c | 14 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2023-06-19 | Class II | Process control | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator c | 7 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-12-16 | Class II | Device Design | Mechanical connection between the tabletop and table base may be lost. | 550 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-08-10 | Class II | Device Design | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to rele | 1,389 (590 US; 799 OUS) (Total) | |
| Siemens Medical Solutions USA, Inc. | UDI-DI | 2022-05-20 | Class II | Process control | During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation. | 195 worldwide, 88 US | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-04-11 | Class II | Device Design | if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm | 51 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-04-11 | Class II | Device Design | if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm | 13 units | |
| Siemens Medical Solutions USA, Inc. | UDI-DI | 2022-02-25 | Class II | Software Design Change | Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and man | 94 U.S. | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-25 | Class II | Software design | After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if | 127 units | |
| Siemens Medical Solutions USA, Inc. | UDI-DI | 2021-10-12 | Class II | Software design | Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during inter | 72 units | 2024-04-11 |
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.