Proteus
PDU Component Assemble
7manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
Record
| Listed by | Ge Hualun Medical Systems Co., Ltd., China |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| 510(k) | K993090 |
| Record published | 2016-08-01 |
| Record revised | 2025-05-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XRa | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 171 |
| Q-RAD System | Carestream Health, Inc. | 159 |
| DRX – Ascend System | Carestream Health, Inc. | 121 |
| FDR Clinica | Drgem Corporation | 41 |
| RADspeed Pro | Shimadzu Corp. | 31 |
| FDR Visionary Suite | Shimadzu Corp. | 17 |
| Exsys DEXi | Drtech Corporation | 15 |
| Del Medical, Inc. | DEL Medical, Inc. | 15 |
| GXR-Es,ecs Diagnostic X-ray System | Drgem Corporation | 14 |
| X-CEL X-RAY Corporation | Arquilla, Inc. | 14 |
| DRX-Evolution Plus System | Carestream Health, Inc. | 12 |
| Carestream DRX-Evolution | Carestream Health, Inc. | 10 |
Showing 12 of 138. All products under System, X-Ray, Stationary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250788 | 2025-08-28 |
| K242678 | 2024-10-01 |
| K231892 | 2023-09-12 |
| K191699 | 2019-07-24 |
| K173612 | 2017-12-11 |
| K172869 | 2017-10-20 |
| K143270 | 2015-02-18 |
Recalls Naming This Product
13 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 |
|---|---|---|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | 510(k) number | 2024-10-24 | Class II | Equipment maintenance | Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List. | 956 systems | |
| GE Healthcare (China) Co., Ltd. | 510(k) number | 2024-07-12 | Class II | Error in labeling | The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injur | 3572 units | |
| GE Medical Systems, LLC | 510(k) number | 2019-08-09 | Class II | Device Design | Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system. | 647 US; 167 OUS | |
| GE Medical Systems, LLC | 510(k) number | 2019-03-29 | Class II | Device Design | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. | 825 (38 US and 787 OUS) in total | 2021-04-15 |
| GE Medical Systems, LLC | 510(k) number | 2015-01-30 | Class II | Device Design | Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator. | 192 (131 US, 61 OUS). | 2015-09-15 |
| GE Medical Systems, LLC | 510(k) number | 2014-12-08 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported. | 3096 (2486 US, 610 OUS). | 2016-02-03 |
| GE Medical Systems, LLC | 510(k) number | 2014-06-04 | Class II | Equipment maintenance | GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems.. There was a reported incident | 3460 | 2015-05-06 |
| GE Medical Systems, LLC | 510(k) number | 2009-08-13 | Not classified | Nonconforming Material/Component | Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the t | 5,943 of total product | 2012-05-24 |
| GE Medical Systems, LLC | 510(k) number | 2007-11-01 | Not classified | Process control | The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976. | 400 Units | 2011-12-18 |
| GE Medical Systems, LLC | 510(k) number | 2007-03-29 | Not classified | Radiation Control for Health and Safety Act | The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators. | 132 | 2012-02-04 |
| GE Medical Systems, LLC | 510(k) number | 2006-05-31 | Not classified | Other | Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled. | 22 units | 2007-12-11 |
| GE Medical Systems, LLC | 510(k) number | 2006-05-31 | Class II | Device Design | An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath | 3,796 units | 2012-07-31 |
| GE Medical Systems, LLC | 510(k) number | 2004-12-30 | Not classified | Other | Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur. | 2716 | 2006-02-21 |
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.