Universal Viewer
Universal Viewer is software for displaying and interpreting medical images and associated clinical reports. It receives images from DICOM-compatible acquisition systems and provides…
Universal Viewer is software for displaying and interpreting medical images and associated clinical reports. It receives images from DICOM-compatible acquisition systems and provides transfer, storage, display, processing and measurement tools.
Viewing functions include distance and angle measurements, annotations, multiplanar reconstruction, maximum-intensity projection and multimodality image fusion or registration. The system operates over healthcare networks on commercial computer platforms.
Listed Item
MD UV 8.1 Medical Device
Mammography Conditions
Mammographic interpretation requires a monitor meeting applicable regulatory and technical requirements. Lossy-compressed mammograms and digitized film-screen images are not intended for primary interpretation through the viewer.
16manufacturers in China registered for this device type
2catalogue 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) | K211312 |
| Record published | 2024-10-02 |
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 |
|---|---|---|
| 8.1 | In distribution | |
| 8 | 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
2 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 |
|---|---|---|---|---|---|---|
| GE Healthcare GmbH | 510(k) number | 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 |
| 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 |
Recalls
33 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 |
|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | 4 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 | 2653 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 | |
| 2024-10-03 | 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 2023-09-14 | 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 | |
| 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 | |
| 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 | |
| 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 |
| 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 |
| 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 |
| 2015-09-28 | 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 |
| 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.