| 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 | 00842000100126 | 6.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 6 | 00842000100966 | 10.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 7 | 00842000100683 | 6.5 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | iConnect Access | |
| 8 | 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 | |
| 9 | 00842000100447 | 11.0 | Correcting entry. | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | |
| 10 | 00842000100072 | 7.1.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 11 | 00842000100058 | 11.1.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 12 | 00842000100409 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 13 | 00842000100829 | 13.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | ||
| 14 | 00842000100805 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 15 | 00842000100331 | 11.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 16 | 00842000100935 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 17 | 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 | |
| 18 | 00842000100607 | 7.1.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 19 | 00842000100560 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 20 | 00842000100508 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 21 | 00842000100478 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 22 | 00842000100461 | 11.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity Pacs | ||
| 23 | 00842000100089 | 7.1.1 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 24 | 00842000100034 | 10.1 | DQK | Computer, Diagnostic, Programmable | 2 | Merge HEMO | ||
| 25 | 00842000100348 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 26 | 00842000100706 | 7.3 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 27 | 00842000100775 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 28 | 00842000100676 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 29 | 00842000100577 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 30 | 00842000100454 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 31 | 00842000100737 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 32 | 00842000100614 | 8.32 | LLZ | System, Image Processing, Radiological | 2 | RadSuite | ||
| 33 | 00842000100515 | 77-00327-00 | Merge Hemo 77-00327-00 Link Assembly | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo Link Assembly | |
| 34 | 00842000100041 | 10.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 35 | 00842000100003 | 7.0 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 36 | 90842000100914 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 37 | 00842000100782 | 7.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 38 | 00842000100720 | 7.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 39 | 00842000101031 | 6.4 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 40 | 00842000101024 | 9.0 | Correcting entry. | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | |
| 41 | 00842000101017 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 42 | 00842000100928 | 12.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 43 | 00842000100881 | 6.3 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 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 | 07649990819006 | 12.5.1 | The OsiriX MD software is an interactive image display and navigation program th The OsiriX MD software is an interactive image display and navigation program that was designed for medical imaging modalities. It supports all types of images generated by variety of imaging equipment and scanners available today. It supports the DICOM standard for image communication as well as a variety of other image formats used in academic and research community.OsiriX MD will act as a DICOM viewer capable of connecting to a DICOM network. OsiriX MD will be able to connect to various networked PACS, modalities and other DICOM nodes through the DICOM protocol over a TCP/IP network. OsiriX MD will provide manipulation tools for medical images. It also provides the necessary tools to query DICOM nodes, retrieve images from them and send images. OsiriX MD will also permit the efficient storage, and retrieval of medical images for imaging workstations.OsiriX MD is tailored for large sets of multidimensional and multi-modality images such as combined PET-CT studies that require three dimensional image fusion and volume rendering. The software is developed on MacOS platform. The software was developed in Objective-C in Apple Xcode development environment. In the design of the software a special attention was given to adapt the user interface to navigating through large sets of image data. The graphical user interface also uses the MacOS interface. Users can change and customize the software by adding and removing tools and items from the program toolbar and menu bars. This allows for adapting the software for number of functions and avoiding the users to be overwhelmed by an excessive number of unnecessary tools and functions that are not always needed. | OsiriX MD | PIXMEO SÀRL | |
| 2 | 07640176970535 | NS053 | NAVIPLAN, CT Planning Software for Total Hip Replacement | Naviplan | NAVISWISS AG | |
| 3 | 07630971257610 | 5.3SWVE | MyHip Verifier | MyHip Verifier | MEDACTA INTERNATIONAL SA | |
| 4 | 07630971257603 | 5.3SWPL | MyHip Planner | MyHip Planner | MEDACTA INTERNATIONAL SA | |
| 5 | 07630971243378 | 05.07.001SWO | MyPAO Planning report | MyPAO Planning report | MEDACTA INTERNATIONAL SA | |
| 6 | 07630345725905 | 98.46.WEBPSPINE | WebPlanner Spine Software | MySpine Webplanner & MyBalance | MEDACTA INTERNATIONAL SA | |
| 7 | 07630345725899 | 98.46.MYPSPINE | MyPlanner Spine | MySpine Webplanner & MyBalance | MEDACTA INTERNATIONAL SA | |
| 8 | 07630039100803 | 3 | StorM-Base 2.0 | STORZ MEDICAL AG | ||
| 9 | 07629999685093 | 2.16 | MSOFT Dental Planning System | SWISSMEDA AG | ||
| 10 | 07629999628410 | 2.19.0 | MSOFT Dental Planning System | SWISSMEDA AG | ||
| 11 | 07629999614178 | 2.17.1 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 12 | 07629999065512 | 2.15.4 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 13 | 07629999062177 | 2.20.0 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 14 | 07629999061569 | 2.15.3 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 15 | 07629999057654 | 2.15.2 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 16 | 07629999056985 | 2.15.1 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 17 | 07629999056220 | 2.15 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 18 | 07629999054356 | 2.14.3 | MSOFT Dental Planning System | SWISSMEDA AG | ||
| 19 | 07629999052505 | 2.14.2 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 20 | 07629999052109 | 2.14.1 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 21 | 07629999048713 | 2.14 | Swissmeda Dental Planning System | SWISSMEDA AG | ||
| 22 | 07613327459081 | 01030300 | 0103-0300 | HipCheck | STRYKER CORPORATION | |
| 23 | INTUITION9 | Intuition Thin Client | Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET Thin Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities. | Intuition | TERARECON INC. | |
| 24 | INTUITION8 | Intuition Client | Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or A Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities. | Intuition | TERARECON INC. | |
| 25 | INTUITION7 | AQNet Server | The AquariusNET Server, also known as iNtuition Server, receives, stores, transm The AquariusNET Server, also known as iNtuition Server, receives, stores, transmits and post-processes medical images from acquisition devices, in both DICOM and non-DICOM format. | iNtuition | TERARECON INC. | |
| 26 | INTUITION6 | Aquarius Web | AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNt AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a focus on 3D rendering, additionally providing workflow and scene support. | iNtuition | TERARECON INC. | |
| 27 | INTUITION5 | iNtuition Mobile | iNtuition Mobile (aka AQMobile) refers to the client viewer designed for mobile devices. | iNtuition | TERARECON INC. | |
| 28 | INTUITION4 | iNtuitionEMV | iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer ru iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer running within a web browser. Limited to the context of iEMV usage on a mobile device, it is referred to as iEMV Mobile. | iNtuition | TERARECON INC. | |
| 29 | INTUITION3 | iNtuitionReview | iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image clien iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image client viewer that provides multi-monitor and multi-modality image review. | iNtuition | TERARECON INC. | |
| 30 | INTUITION2 | ThinClient | ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities. | iNtuition | TERARECON INC. | |
| 31 | INTUITION12 | Intuition Server | The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, sto The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, transmits and post-processes medical images from acquisition devices in DICOM and non-DICOM formats. | Intuition | TERARECON INC. | |
| 32 | INTUITION11 | Intuition Web | Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) i Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) is a version of Intuition EMV (aka iNtuitionEMV) with a focus on 3D rendering, additionally providing workflow and scene support. | Intuition | TERARECON INC. | |
| 33 | INTUITION10 | Intuition Mobile | Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewe Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewer designed for mobile devices. | Intuition | TERARECON INC. | |
| 34 | INTUITION1 | Aquarius iNtuition Client | Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstatio Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities. | iNtuition | TERARECON INC. | |
| 35 | INTUITION04 | Intuition04 | Intuition | Intuition (also referred to as Aquarius Intuition) is a medical device comprised Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse.Intuition is comprised of six (6) separate client viewers: Intuition Client with Emergency Lung Docker, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile. | Intuition | TERARECON INC. |
| 36 | 07540263000025 | 3.0 | The VMS+ system is an adjunct to existing ultrasound imaging systems and is inte The VMS+ system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired. | Ventripoint Medical System Plus (VMS+) | VENTRIPOINT DIAGNOSTICS LTD | |
| 37 | 07392532209413 | Version 3.1 | 54500395IV31 | Case Viewer | Simplant | DENTSPLY IMPLANTS NV |
| 38 | 07392532208423 | Version 3.1 | 54500394E31 | Simplant Editor | Simplant | DENTSPLY IMPLANTS NV |
| 39 | 07392532208416 | Version 18.5 | 54500277V185 | Simplant View | Simplant | DENTSPLY IMPLANTS NV |
| 40 | 07392532206269 | Version 18.5 | 54500277P185 | Simplant Pro | Simplant | DENTSPLY IMPLANTS NV |
| 41 | 07392532205583 | Version 3 | 54500395IV3 | Case Viewer | Simplant | DENTSPLY IMPLANTS NV |
| 42 | 07392532204814 | Version 3 | 54500394E3 | Simplant Editor | Simplant | DENTSPLY IMPLANTS NV |
| 43 | 07392532191251 | Version 18 | 54500277P18 | Simplant Pro | Simplant | DENTSPLY IMPLANTS NV |
| 44 | 07392532191237 | Version 18 | 54500277O18 | Simplant OneShot | Simplant | DENTSPLY IH, INC. |
| 45 | 07392532191220 | Version 18 | 54500277V18 | Simplant View | Simplant | DENTSPLY IMPLANTS NV |
| 46 | 07392532181276 | Version 2 | 54500395IV | SIMPLANT Viewer | SIMPLANT® | DENTSPLY IMPLANTS NV |
| 47 | 07392532181252 | Version 2 | 54500394E2 | SIMPLANT Editor | SIMPLANT® | DENTSPLY IMPLANTS NV |
| 48 | 07392532178030 | Version 17 | 54500277A | SIMPLANT Pro | SIMPLANT® | DENTSPLY IMPLANTS NV |
| 49 | 07350092810432 | 16.2 | Sectra Orthopaedic Package is intended to assist the user when doing preoperativ Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images.For example the Sectra Orthopaedic Package shall:• Assist the orthopaedic surgeons in choosing which implants to use.• Assist the orthopaedic surgeons in choosing where to place cut lines etc.• Assist the orthopaedic surgeons in following-up of surgical procedures.• Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery.• Assist the radiologist in making MSK measurements.• Assist the user in producing outputs for post-processing such as 3D prints of anatomical models.Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists. | Sectra Orthopedic Package | SECTRA AB | |
| 50 | 07350092810418 | 24.2 | Sectra Workstation is intended for the display, manipulation and diagnostic revi Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and ophthalmology.Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review.Only for the United States:- Mammographic images must be reviewed on a monitor approved by FDA for this purpose.Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but it can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used.Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used e.g. size, resolution and contrast. | Sectra Workstation | SECTRA AB |