Centricity
MD Cpacs RA1000 4.0 Medical Device
16manufacturers in China registered for this device type
7catalogue numbers in this listing
23510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems 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 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | GE Healthcare GmbH, Germany |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K110875 |
| Record published | 2020-01-27 |
| Record revised | 2023-10-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPACS 7.0 | In distribution | |
| UNIVERSAL VIEWER 6.0 | In distribution | |
| CPACS 6.0 | In distribution | |
| UNIVERSAL VIEWER 7.0 | In distribution | |
| UNIVERSAL VIEWER ZFP CLIENT 6.0 | In distribution | |
| CPACS 4.0 | In distribution | |
| CPACS RA1000 4.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253639 | 2026-01-08 |
| K241300 | 2024-07-02 |
| K221680 | 2023-03-01 |
| K211312 | 2021-05-21 |
| K201103 | 2020-09-25 |
| K182419 | 2018-12-14 |
| K180641 | 2018-05-04 |
| K160937 | 2016-08-01 |
| K153355 | 2016-03-16 |
| K150420 | 2015-05-26 |
| K143361 | 2015-03-26 |
| K131977 | 2013-09-17 |
| K131118 | 2013-05-16 |
| K130069 | 2013-04-05 |
| K123174 | 2012-11-16 |
| K121200 | 2012-11-02 |
| K120221 | 2012-03-30 |
| K110875 | 2011-05-05 |
| K110834 | 2011-04-26 |
| K103458 | 2011-03-04 |
| K101166 | 2010-10-07 |
| K072986 | 2007-11-20 |
| K052995 | 2005-11-08 |
Recalls Naming This Product
38 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 |
|---|---|---|---|---|---|---|---|
| GE Healthcare GmbH | 510(k) number | 2026-07-31 | Not classified | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t | 1856 systems | |
| GE Healthcare GmbH | 510(k) number | 2026-07-31 | Not classified | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t | 1298 systems | |
| GE Healthcare GmbH | 510(k) number | 2026-07-31 | Not classified | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t | 1443 systems | |
| GE Healthcare GmbH | 510(k) number | 2026-07-31 | Not classified | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t | 116 systems | |
| GE Healthcare GmbH | 510(k) number | 2026-07-31 | Not classified | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t | 169 systems | |
| GE Healthcare GmbH | 510(k) number | 2026-07-31 | Not classified | Under Investigation by firm | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t | 250 systems | |
| GE Medical Systems, LLC | UDI-DI | 2026-01-30 | Class II | Software design | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially i | 1568 units | |
| GE Medical Systems, LLC | 510(k) number | 2026-01-30 | Class II | Software design | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially i | 797 units | |
| GE Healthcare GmbH | 510(k) number | 2026-01-16 | Class II | Device Design | Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient T | 250 units | |
| GE Healthcare GmbH | 510(k) number | 2025-02-19 | Class II | Software design | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be id | 2653 units | |
| GE Healthcare GmbH | UDI-DI | 2025-02-19 | Class II | Software design | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be id | 4 units | |
| GE Healthcare GmbH | 510(k) number | 2024-10-03 | Class II | Software Manufacturing/Software Deployment | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate pati | 120 units | |
| GE Healthcare GmbH | 510(k) number | 2024-08-29 | Class II | Process control | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM struc | 1500 units | |
| GE Healthcare GmbH | 510(k) number | 2024-08-05 | Class II | Device Design | GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study. | 2138 units | |
| GE Healthcare GmbH | 510(k) number | 2024-07-23 | Class II | Software Design Change | Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and on | 803 units | |
| GE Healthcare GmbH | 510(k) number | 2023-09-14 | Class II | Software design | GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer | 329 units | |
| GE Healthcare GmbH | UDI-DI | 2023-09-08 | Class II | Software design | When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer. | 85 units | |
| GE Healthcare GmbH | 510(k) number | 2023-03-28 | Class II | Other | GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. | 329 units | |
| GE Medical Systems, LLC | 510(k) number | 2022-10-28 | Class II | Software Manufacturing/Software Deployment | There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study. | 236 units | |
| GE Medical Systems, LLC | 510(k) number | 2022-07-15 | Class II | Process design | Inaccurate Distance and Area measurements with use of Global Stack viewport. | 1,690 devices | |
| GE Medical Systems, LLC | 510(k) number | 2022-06-14 | Class II | Software design | The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. | 47 installations | 2024-01-16 |
| GE Medical Systems, LLC | 510(k) number | 2022-06-08 | Class II | Software design | Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP) | 1,934 units | |
| GE Medical Systems, LLC | 510(k) number | 2022-04-28 | Class II | Software design | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy | 488 units | |
| GE Medical Systems, LLC | 510(k) number | 2022-04-28 | Class II | Software design | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy | 676 units | |
| GE Medical Systems, LLC | 510(k) number | 2021-10-15 | Class II | Software design | There is a potential to display incomplete patient imaging study. | 638 devices | 2026-08-17 |
| GE Medical Systems, LLC | UDI-DI | 2021-08-12 | Class II | Other | A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA). | 49 | 2024-08-22 |
| GE Medical Systems, LLC | 510(k) number | 2021-08-06 | Class II | Software design | Image acquisition failures and synchronization failure with the Centricity Enterprise Archive | 462 (279 US; 183 OUS) | |
| GE Medical Systems, LLC | UDI-DI | 2021-03-19 | Class II | Under Investigation by firm | When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s compariso | 112 units | 2023-08-11 |
| GE Medical Systems, LLC | 510(k) number | 2019-12-16 | Class II | Software design | Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis. | 205 | 2023-10-05 |
| GE Medical Systems, LLC | 510(k) number | 2019-05-17 | Class II | Software design | There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. | 292 units | 2023-11-20 |
| GE Medical Systems, LLC | 510(k) number | 2019-05-16 | Class II | Device Design | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive. | 145 (87 US 103 OUS) | 2023-04-14 |
| GE Medical Systems, LLC | 510(k) number | 2019-05-16 | Class II | Device Design | There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive. | 92 (47 US 103 OUS) | 2023-04-14 |
| GE Medical Systems, LLC | 510(k) number | 2018-12-20 | Class II | Software design | When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagn | 297 (131 US; 166 OUS) | 2021-04-09 |
| GE Medical Systems, LLC | 510(k) number | 2018-11-09 | Class II | Software design | Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied | 508 units | 2026-05-18 |
| GE Medical Systems, LLC | 510(k) number | 2018-10-11 | Class II | Software design | Synchronization failure | 73 | 2023-03-20 |
| GE Medical Systems, LLC | 510(k) number | 2018-08-30 | Class II | Component design/selection | Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. | 1 | 2022-08-31 |
| GE Healthcare GmbH | 510(k) number | 2018-01-25 | Class II | Software design | Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. | 252 | 2023-11-02 |
| GE Healthcare GmbH | 510(k) number | 2015-09-28 | Class II | Software design | Inaccurate distance measurements with magnified projection X-ray images. | Centricity Universal Viewer versions 6.0 and higher 5 units | 2018-04-11 |
Recalls
22 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-11-03 | Class II | Device Design | GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information. | 1221 units | |
| 2025-02-19 | Class II | Software design | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be id | 82 units | |
| 2025-02-19 | Class II | Software design | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be id | 1563 units | |
| 2025-02-19 | Class II | Software design | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be id | 633 units | |
| 2024-08-08 | Class II | Device Design | The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization o | 3 units | |
| 2024-08-08 | Class II | Device Design | The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization o | 574 units | |
| 2023-09-14 | Class II | Software design | GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer | 17 units | |
| 2023-09-14 | Class II | Software design | GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer | 149 units | |
| 2023-09-08 | Class II | Software design | When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer. | 57 units | |
| 2023-03-28 | Class II | Other | GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. | 153 units | |
| 2023-03-28 | Class II | Other | GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. | 17 units | |
| 2018-02-23 | Class II | Software design | A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may | 569 units | 2024-09-30 |
| 2018-01-25 | Class II | Software design | Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. | 44 | 2023-11-02 |
| 2015-09-28 | Class II | Software design | Inaccurate distance measurements with magnified projection X-ray images. | Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 an | 2018-04-11 |
| 2015-09-16 | Class II | Software Design Change | Images may be missing when a system parameter MapRoute is set to a value greater than 1. | 921 systems are impacted. | 2017-01-05 |
| 2015-08-11 | Class II | Software design (manufacturing process) | Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1. | 26 systems | 2017-01-05 |
| 2015-08-11 | Class II | Software design (manufacturing process) | Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1. | 82 systems | 2017-01-05 |
| 2014-04-03 | Class II | Software design | It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed s | 297 units | 2015-06-05 |
| 2013-08-26 | Class II | Software design | There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbnail navigator. This i | 28 units | 2016-05-16 |
| 2013-06-11 | Class II | Software design | GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration | 623 units | 2016-06-10 |
| 2013-02-18 | Class II | Software design | Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp | 128 systems | 2016-05-16 |
| 2013-02-18 | Class II | Software design | It was reported from a complaint that study category labels of “Prior” and “Baseline” and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder. | 118 | 2017-07-31 |
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.