| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00842000100751 | 11.1 | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio V11.1 | ||
| 2 | 00842000100980 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access 8.1 | ||
| 3 | 00842000100027 | 9.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 4 | 00842000100010 | 10.0.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 5 | 00842000100133 | 1.0 | Standalone software application. A universal workflow (non-medical tool) on Merg Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform. | LLZ | System, Image Processing, Radiological | 2 | iConnect Enterprise Workflow with Merge PACS | |
| 6 | 00842000100126 | 6.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 7 | 00842000100966 | 10.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 8 | 00842000100683 | 6.5 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | iConnect Access | |
| 9 | 00842000100645 | 6.4 | Software application that provides internet access to multi-modality softcopy me Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 10 | 00842000100447 | 11.0 | Correcting entry. | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | |
| 11 | 00842000100072 | 7.1.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 12 | 00842000100058 | 11.1.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 13 | 00842000100409 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 14 | 00842000100829 | 13.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | ||
| 15 | 00842000100805 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 16 | 00842000100331 | 11.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 17 | 00842000100935 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 18 | 00842000100690 | 7.3 | Merge PACS™ is a standards-based medical imaging diagnostic workstation that ser Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.). | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 19 | 00842000100607 | 7.1.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 20 | 00842000100560 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 21 | 00842000100508 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 22 | 00842000100478 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 23 | 00842000100461 | 11.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity Pacs | ||
| 24 | 00842000100089 | 7.1.1 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 25 | 00842000100034 | 10.1 | DQK | Computer, Diagnostic, Programmable | 2 | Merge HEMO | ||
| 26 | 00842000100348 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 27 | 00842000100706 | 7.3 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 28 | 00842000100775 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 29 | 00842000100676 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 30 | 00842000100577 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 31 | 00842000100454 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 32 | 00842000100737 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 33 | 00842000100614 | 8.32 | LLZ | System, Image Processing, Radiological | 2 | RadSuite | ||
| 34 | 00842000100515 | 77-00327-00 | Merge Hemo 77-00327-00 Link Assembly | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo Link Assembly | |
| 35 | 00842000100041 | 10.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 36 | 00842000100003 | 7.0 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 37 | 90842000100914 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 38 | 00842000100782 | 7.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 39 | 00842000100720 | 7.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 40 | 00842000101031 | 6.4 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 41 | 00842000101024 | 9.0 | Correcting entry. | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | |
| 42 | 00842000101017 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 43 | 00842000100928 | 12.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 44 | 00842000100638 | 6.2 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 45 | 00842000100591 | 10.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 46 | 00842000100416 | 11.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 47 | 00842000100300 | 4.2.1 | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite | ||
| 48 | 00842000100065 | 2.0 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Z3D | |
| 49 | 00842000100867 | 4.3 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite | |
| 50 | 00842000100850 | 4.3 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | eFilm Workstation |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00850003095004 | 2.1.2.1 | Computer assisted reading tools designed to aid the radiologist in the detection Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest. | InferRead Lung CT.AI 2.1.2.1 | INFERVISION US INC | |
| 2 | 00850001088015 | 5 | suiteHEART Software is intended to assist trained clinical personnel in the qual suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | suiteHEART | NEOSOFT LLC | |
| 3 | 00850001088008 | 4.0.7 | suiteHEART Software is intended to assist trained clinical personnel in the qual suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | suiteHEART | NEOSOFT LLC | |
| 4 | 00842000101031 | 6.4 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 5 | 00842000101024 | 9.0 | Correcting entry. | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 6 | 00842000101017 | 8.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 7 | 00842000100980 | 8.1 | IBM iConnect Access 8.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 8 | 00842000100935 | 8.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 9 | 00842000100928 | 12.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 10 | 00842000100881 | 6.3 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 11 | 00842000100867 | 4.3 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
| 12 | 00842000100850 | 4.3 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
| 13 | 00842000100843 | 7.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 14 | 00842000100829 | 13.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 15 | 00842000100805 | 8.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 16 | 00842000100782 | 7.1 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 17 | 00842000100775 | 8.0 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 18 | 00842000100768 | 12.0.1 | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 19 | 00842000100751 | 11.1 | Merge Cardio V11.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 20 | 00842000100744 | 12.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 21 | 00842000100737 | 8.0 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 22 | 00842000100720 | 7.0 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 23 | 00842000100713 | 3.7.5 | Merge OrthoCase | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 24 | 00842000100706 | 7.3 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 25 | 00842000100690 | 7.3 | Merge PACS™ is a standards-based medical imaging diagnostic workstation that ser Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.). | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 26 | 00842000100683 | 6.5 | Stand alone software application. | iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 27 | 00842000100676 | 7.2 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 28 | 00842000100652 | 4.2.1 | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 29 | 00842000100645 | 6.4 | Software application that provides internet access to multi-modality softcopy me Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. | Merge iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 30 | 00842000100638 | 6.2 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 31 | 00842000100614 | 8.32 | RadSuite | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 32 | 00842000100607 | 7.1.0 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 33 | 00842000100591 | 10.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 34 | 00842000100577 | 7.0.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 35 | 00842000100560 | 7.0.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 36 | 00842000100508 | 6.6.3.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 37 | 00842000100478 | 7.1.2.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 38 | 00842000100461 | 11.0 | Merge Unity Pacs | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 39 | 00842000100454 | 7.1.2.1 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 40 | 00842000100416 | 11.0 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 41 | 00842000100409 | 7.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 42 | 00842000100348 | 6.6.3.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 43 | 00842000100331 | 11.2 | Standalone software application | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 44 | 00842000100300 | 4.2.1 | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 45 | 00842000100294 | 4.2 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
| 46 | 00842000100287 | 4.2 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
| 47 | 00842000100133 | 1.0 | Standalone software application. A universal workflow (non-medical tool) on Merg Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform. | iConnect Enterprise Workflow with Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 48 | 00842000100126 | 6.3 | Standalone software application. | Merge iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 49 | 00842000100089 | 7.1.1 | Standalone software application. | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 50 | 00842000100072 | 7.1.1 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. |