Nucleus.io
2 catalogue numbers from 25.0, listed by Change Healthcare Canada Company, Canada, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
14recalls 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 | Change Healthcare Canada Company, Canada |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K171130 |
| Record published | 2021-01-15 |
| Record revised | 2023-10-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25.0 | In distribution | |
| 24 | 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 |
|---|---|
| K241981 | 2024-11-12 |
| K181185 | 2018-08-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Change Healthcare Canada Company | 510(k) number | 2023-11-01 | Class II | Software design | Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient’s study. | 454 |
Recalls
12 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 |
|---|---|---|---|---|---|
| 2025-08-13 | Class II | Software Design Change | Due to software issue, radiology reports may not be fully displayed when viewing. | 12 programs | |
| 2023-10-12 | Class II | Software design | Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications. | 282 units | |
| 2021-04-19 | Class II | Software design | A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. | 33 devices | |
| 2021-03-17 | Class II | Software design | Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. | 28 units | |
| 2020-08-25 | Class II | Process design | Software defect which may potentially result in one or more images missing in a study | 5 devices | 2021-02-16 |
| 2016-12-02 | Class II | Software design | Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a newly imported study, and/or study imports that remain in an “in-progress” status. | 17 | 2017-11-24 |
| 2016-07-12 | Class II | Software design | The STAT priority icon was not displayed in the Study List when the study was opened. | 164 devices | 2019-11-20 |
| 2016-02-18 | Class II | Software design | McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient. | 631 devices | 2018-08-28 |
| 2014-05-29 | Class II | Software design | Firm received a complaint that an unreported study performed that day could not be opened from the archive. | 659 | 2017-03-31 |
| 2014-05-05 | Class II | Software design | The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images. | 659 units | 2017-04-13 |
| 2014-04-17 | Class II | Software Design Change | High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List. | 45 | 2016-02-02 |
| 2012-05-29 | Class II | Software design | There is a potential to save reports in RadReport with an Incorrect Final Status. | 516 units | 2013-09-12 |
| 2010-05-07 | Not classified | Software design | Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient. | 100 units | 2012-08-15 |
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.