Iconnect Enterprise Workflow With Merge PACS
Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.
16manufacturers in China registered for this device type
1catalogue number
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 | Merge Healthcare Solutions Inc. |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| 510(k) | K082144 |
| Record published | 2017-02-22 |
| Record revised | 2023-10-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | 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
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 |
|---|---|---|---|---|---|---|---|
| Merge Healthcare Incorporated | 510(k) number | 2017-05-24 | Class II | Software design (manufacturing process) | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. | 160 sites potentially have the affected versions | 2019-10-15 |
| Merge Healthcare Incorporated | 510(k) number | 2017-05-08 | Class II | Software design (manufacturing process) | Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing. | 47 sites potentially have the affected versions | 2019-08-05 |
| Merge Healthcare Incorporated | 510(k) number | 2017-05-08 | Class II | Software design (manufacturing process) | When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis. | 47 sites have the potentially affected versions | 2019-08-08 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-04 | Class II | Software design | Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. | 29 sites have the potentially affected software | 2019-04-08 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-04 | Class II | Software design | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. | 248 sites potentially have the affected versions | 2021-04-23 |
| Merge Healthcare Incorporated | 510(k) number | 2016-03-28 | Class II | Software design | The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing. | 534 sites potentially have the affected versions | 2021-04-23 |
| Merge Healthcare Incorporated | 510(k) number | 2016-03-28 | Class II | Component design/selection | Cut lines on the image may present horizontally rather than vertically. | 537 sites potentially have the affected versions | 2021-05-07 |
| Merge Healthcare Incorporated | 510(k) number | 2016-02-05 | Class II | Software design | When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same. | 49 sites potentially have the affected versions | 2016-10-25 |
| Merge Healthcare Incorporated | 510(k) number | 2016-01-30 | Class II | Software design | Studies coming over via telmed were missing patient’s DOB, procedure, and referring physician. | 109 sites have the affected versions | 2019-04-08 |
| Merge Healthcare Incorporated | 510(k) number | 2016-01-30 | Class II | Software design | A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations. | 208 sites have the affected versions | 2021-05-07 |
| Merge Healthcare Incorporated | 510(k) number | 2016-01-30 | Class II | Software design | The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. | 93 sites have the affected version | 2020-10-05 |
| Merge Healthcare Incorporated | 510(k) number | 2016-01-30 | Class II | Software design | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingeste | 146 sites potentially have the affected versions for both pr | 2021-05-07 |
| Merge Healthcare Incorporated | 510(k) number | 2016-01-30 | Class II | Software design | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingeste | 146 sites may have the affected version for both products | 2021-05-07 |
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.