| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B148WSONE1820 | 1.8.2 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 2 | B148WSONE1810 | 1.8.1 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 3 | B148WSONE1840 | 1.8.4 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 4 | B148WSONE1830 | 1.8.3 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 5 | B148WSONE1850 | 1.8.5 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 6 | B148WSONE1910 | 1.9.1 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 7 | B148WSONE1900 | 1.9.0 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 8 | B148WSONE1880 | 1.8.8 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 9 | B148WSONE1870 | 1.8.7 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ | |
| 10 | B148WSONE1860 | 1.8.6 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | LLZ | System, Image Processing, Radiological | 2 | WorkstationOne™ |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00842000101031 | 6.4 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 2 | 00842000101024 | 9.0 | Correcting entry. | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 3 | 00842000101017 | 8.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 4 | 00842000100980 | 8.1 | IBM iConnect Access 8.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 5 | 00842000100935 | 8.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 6 | 00842000100928 | 12.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 7 | 00842000100881 | 6.3 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 8 | 00842000100867 | 4.3 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
| 9 | 00842000100850 | 4.3 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
| 10 | 00842000100843 | 7.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 11 | 00842000100829 | 13.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 12 | 00842000100805 | 8.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 13 | 00842000100782 | 7.1 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 14 | 00842000100775 | 8.0 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 15 | 00842000100768 | 12.0.1 | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 16 | 00842000100751 | 11.1 | Merge Cardio V11.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 17 | 00842000100744 | 12.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 18 | 00842000100737 | 8.0 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 19 | 00842000100720 | 7.0 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 20 | 00842000100713 | 3.7.5 | Merge OrthoCase | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 21 | 00842000100706 | 7.3 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 22 | 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. | |
| 23 | 00842000100683 | 6.5 | Stand alone software application. | iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 24 | 00842000100676 | 7.2 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 25 | 00842000100652 | 4.2.1 | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 26 | 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. | |
| 27 | 00842000100638 | 6.2 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
| 28 | 00842000100614 | 8.32 | RadSuite | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 29 | 00842000100607 | 7.1.0 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 30 | 00842000100591 | 10.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 31 | 00842000100577 | 7.0.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 32 | 00842000100560 | 7.0.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 33 | 00842000100508 | 6.6.3.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 34 | 00842000100478 | 7.1.2.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 35 | 00842000100461 | 11.0 | Merge Unity Pacs | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 36 | 00842000100454 | 7.1.2.1 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 37 | 00842000100416 | 11.0 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
| 38 | 00842000100409 | 7.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 39 | 00842000100348 | 6.6.3.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 40 | 00842000100331 | 11.2 | Standalone software application | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 41 | 00842000100300 | 4.2.1 | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | ||
| 42 | 00842000100294 | 4.2 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
| 43 | 00842000100287 | 4.2 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
| 44 | 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. | |
| 45 | 00842000100126 | 6.3 | Standalone software application. | Merge iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
| 46 | 00842000100089 | 7.1.1 | Standalone software application. | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 47 | 00842000100072 | 7.1.1 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 48 | 00842000100065 | 2.0 | Stand alone software application. | Merge Z3D | MERGE HEALTHCARE SOLUTIONS INC. | |
| 49 | 00842000100058 | 11.1.2 | Standalone software application | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
| 50 | 00842000100041 | 10.3 | Standalone software application. | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. |