Enterprise Imaging Xero Viewer
Enterprise Imaging XERO Viewer 8.x
16manufacturers in China registered for this device type
4catalogue numbers in this listing
11510(k) clearances naming this product code
37recalls 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 | Agfa Healthcare Inc., Canada |
|---|---|
| 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) | K143397 |
| Record published | 2018-03-14 |
| Record revised | 2023-10-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2019-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8 | In distribution | |
| 8.1.2 | Withdrawn | |
| 8.1.1 | Withdrawn | |
| Enterprise Imaging Xero Viewer 8.1 | Withdrawn |
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 |
|---|---|
| K081976 | 2008-07-28 |
| K080013 | 2008-01-17 |
| K073271 | 2007-12-05 |
| K071972 | 2007-07-30 |
| K071297 | 2007-06-22 |
| K053458 | 2005-12-22 |
| K050751 | 2005-04-21 |
| K040555 | 2004-05-26 |
| K040344 | 2004-05-12 |
| K022292 | 2002-09-12 |
| K010571 | 2001-03-28 |
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 |
|---|---|---|---|---|---|---|
| Agfa Healthcare N.V. | 510(k) number | 2024-09-06 | Class II | Software design | Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with re | 801 units |
| Agfa Healthcare N.V. | 510(k) number | 2022-12-05 | Class II | Software design | There is a software defect that can cause issues with images. | 110 units |
Recalls
11 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 |
|---|---|---|---|---|---|
| 2016-12-22 | Class II | Software design | A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm. | 10 | 2021-08-27 |
| 2015-09-01 | Class II | Software design | Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct. | 19 | 2020-12-15 |
| 2015-06-26 | Class II | Other | Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect. | 2 | 2016-01-27 |
| 2014-04-30 | Class II | Software design | Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service. | One | 2014-09-18 |
| 2014-01-08 | Class II | Unknown/Undetermined by firm | Patient name displayed (printed) on the Patient Report was the wrong patient name. | 14 | 2014-02-28 |
| 2013-09-19 | Class II | Software in the Use Environment | System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. | 4 | 2013-10-24 |
| 2013-03-15 | Class II | Software design | Software design error in IMPAX CV 7.8 SU3 | 2 | 2014-04-01 |
| 2013-03-15 | Class II | Software design | Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital’s electronic health record (EHR) system. | 26 | 2014-01-09 |
| 2012-08-09 | Class II | Process design | Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa’s Medical Image Storage Devices – Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS). | 535 | 2015-12-08 |
| 2012-07-27 | Class II | Software change control | Content entered into the “Conclusions” free text box on the Report Writer screen was not represented on the final printed report. | 280 | 2015-01-13 |
| 2012-07-10 | Class II | Error in labeling | When users selected “Left stenosis” in the “Graft Duplex Conclusion” section in IMPAX CV Reporting Non-Invasive(NIV) module, “Right stenosis” appeared in the sentence display within the printed representation of the report. | 6 | 2013-10-29 |
| 2011-06-06 | Not classified | Pending | Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR). | 280 | 2014-05-08 |
| 2011-06-06 | Not classified | Software design | Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable. | 323 | 2013-07-02 |
| 2011-06-06 | Not classified | Software design | Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it. | 323 units | 2012-06-26 |
| 2011-04-05 | Not classified | Other | Software issue that occurs after dictation of a study. | 95 units | 2011-09-15 |
| 2011-03-21 | Not classified | Other | Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration. | 536 | 2011-11-29 |
| 2011-02-10 | Not classified | Device Design | A discrepancy in the validation testing which resulted in the product not performing as intended. | One | 2011-09-15 |
| 2011-01-27 | Not classified | Other | Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports. | 107 | 2011-03-29 |
| 2010-10-22 | Not classified | Other | Product did not receive UL Certification | 26 units | 2011-02-01 |
| 2010-06-11 | Not classified | Other | Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators. | 358 | 2013-07-02 |
| 2010-04-22 | Not classified | Nonconforming Material/Component | The RF tags on the white protection sheets of the media stacks were incorrect. | 180 boxes | 2011-02-01 |
| 2009-07-16 | Not classified | Software design | Measurements are inaccurate on multiple workstations. | One unit | 2011-04-28 |
| 2009-06-22 | Not classified | Software design | After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system. | 97 units | 2010-07-22 |
| 2009-05-07 | Not classified | Other | HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed in the HeartStation Client interface an | 9 units | 2010-07-27 |
| 2009-04-15 | Not classified | Other | User could modify a measurement’s units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM. | 6 devices | 2011-10-13 |
| 2008-12-24 | Not classified | Software design | Polling procedure may fail when multiple merge/split is carried out. | 5 units | 2010-04-01 |
| 2008-06-04 | Not classified | Software design | The IMPAX client failed to “refresh” the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the “active” study. | 371 units | 2009-10-09 |
| 2008-02-22 | Not classified | Software design | Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Repo | 5 units | 2010-07-27 |
| 2007-07-27 | Not classified | Software design | Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured. | 6 units | 2008-10-10 |
| 2007-06-28 | Not classified | Software design | Text and Images may not be synchronized. | 154 units | 2011-03-03 |
| 2007-06-21 | Not classified | Software design | MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient. | 43 units | 2008-08-04 |
| 2007-05-14 | Not classified | Software change control | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. | 946 units (total for both types of software) | 2010-12-09 |
| 2007-05-14 | Not classified | Software change control | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. | 946 units (total) | 2010-12-09 |
| 2007-02-15 | Not classified | Software design | Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient. | 879 units | 2009-06-30 |
| 2006-08-08 | Not classified | Other | Failed CAD displayed as ‘No Findings’ | 20 Impax 5.2 Mammo licenses were issued domestically. | 2007-02-20 |
| 2006-06-30 | Not classified | Other | Possible corrupted image appearing after System Start. | 2 units | 2006-09-05 |
| 2005-11-18 | Not classified | Other | Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis. | 2630 units | 2009-06-30 |
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.