Merge Unity PACS
5 catalogue numbers from 11.2, listed by Merge Healthcare Solutions Inc., under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
5catalogue numbers in this listing
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) | K041935 |
| Record published | 2017-11-30 |
| 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 |
| Distribution end date | 2021-09-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11.2 | In distribution | |
| 12.0 | In distribution | |
| 11.1.2 | In distribution | |
| 11.0 | In distribution | |
| 13.0 | 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
Recalls Naming This Product
6 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 | 2017-08-14 | Class II | Process design | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. | 98 sites have the potentially affected software | 2019-05-08 |
| Merge Healthcare Incorporated | 510(k) number | 2017-08-07 | Class II | Process design | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. | 11 sites have potentially affected software | 2020-05-18 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-08 | Class II | Software design | The software is not adding the correct tomo image. | 28 sites potentially have the affected software | 2017-03-06 |
| Merge Healthcare Incorporated | 510(k) number | 2016-04-08 | Class II | Software design | Reports were missing demographic header information when they were faxed to referring physicians. | 9 sites potentially have the affected version | 2017-03-17 |
| Merge Healthcare Incorporated | 510(k) number | 2015-10-15 | Class II | Software design | The software fails to associate to the correct MG image if there are two images for the same view. | 9 sites potentially have the effected software | 2021-04-23 |
| Merge Healthcare Incorporated | 510(k) number | 2015-07-23 | Class II | Software design | The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm. | 9 sites potentially have the affected version | 2016-10-07 |
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.