| 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 | 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 | 00882916000523 | 2.1 | TruPlan | CIRCLE CARDIOVASCULAR IMAGING INC | ||
| 2 | 00882916000516 | 1.x | v1.x and v2.0 | TruPlan | CIRCLE CARDIOVASCULAR IMAGING INC | |
| 3 | 00882916000011 | 5.x | cvi42 | CIRCLE CARDIOVASCULAR IMAGING INC | ||
| 4 | 00882916000004 | 5.6 | Cardiac MR & CT imaging software application | cvi42 | CIRCLE CARDIOVASCULAR IMAGING INC | |
| 5 | 00880304992863 | CG100 | CG100 | MOVE FORWARD SOFTWARE | BIOMET ORTHOPEDICS, LLC | |
| 6 | 00880304990050 | CG006 | CG006 | MOVE FORWARD REPORT RUSH | BIOMET ORTHOPEDICS, LLC | |
| 7 | 00880304990043 | CG005 | CG005 | MOVE FORWARD REPORT MRI | BIOMET ORTHOPEDICS, LLC | |
| 8 | 00880304990036 | CG004 | CG004 | MOVE FORWARD REPORT 16+ | BIOMET ORTHOPEDICS, LLC | |
| 9 | 00880304990029 | CG003 | CG003 | MOVE FORWARD REPORT 10-15 | BIOMET ORTHOPEDICS, LLC | |
| 10 | 00880304990012 | CG002 | CG002 | MOVE FORWARD REPORT 4-9 | BIOMET ORTHOPEDICS, LLC | |
| 11 | 00880304990005 | CG001 | CG001 | MOVE FORWARD REPORT 1-3 | BIOMET ORTHOPEDICS, LLC | |
| 12 | 00869958000117 | ZMED-2XYAC-019 | ZMED-2XYAC-019 | The Clarity System delivers significant capabilities to improve the contrast, co The Clarity System delivers significant capabilities to improve the contrast, color, saturation and sharpness of surgical video. | Clarity | Z MICROSYSTEMS, INC. |
| 13 | 00869126000451 | Smart Stitching | A software application that allows post-capture positioning and joining of indiv A software application that allows post-capture positioning and joining of individual images, to produce an additional composite image for a two-dimensional image review. | Smart Stitching | OSKO, INC. | |
| 14 | 00869047000431 | 4.X.X | The VidiStar PACS & DICOM Viewer Software system is a picture archiving and comm The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. | VidiStar PACS & DICOM Viewer Software | FUJIFILM HEALTHCARE AMERICAS CORPORATION | |
| 15 | 00868772000174 | InTouch Imaging | InTouch Health | INTOUCH TECHNOLOGIES, INC. | ||
| 16 | 00868579000247 | 3 | VMA Motion Normalizer (Console, Table, and Upright assemblies) | VMA Motion Normalizer | ORTHO KINEMATICS, INC. | |
| 17 | 00868579000230 | 3 | VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console) | VMA Image Acquisition Software | ORTHO KINEMATICS, INC. | |
| 18 | 00868579000223 | 3 | VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site | VMA DataLink Software | ORTHO KINEMATICS, INC. | |
| 19 | 00868579000216 | 2.3 | VMA DataLink Software | ORTHO KINEMATICS, INC. | ||
| 20 | 00868579000209 | 2 | VMA | ORTHO KINEMATICS, INC. | ||
| 21 | 00868466000220 | IQQA-BodyImaging | IQQA-BodyImaging is an image analysis software for reviewing body imaging studie IQQA-BodyImaging is an image analysis software for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners | EDDA TECHNOLOGY | EDDA TECHNOLOGY, INC. | |
| 22 | 00868466000213 | IQQA-Liver Multimodality | IQQA-Liver is an image analysis software for reviewing multiphase images derived IQQA-Liver is an image analysis software for reviewing multiphase images derived from CT and MR scanners | EDDA TECHNOLOGY | EDDA TECHNOLOGY, INC. | |
| 23 | 00868466000206 | IQQA-Chest | IQQA-Chest is an image analysis CAD software used during the review of digital c IQQA-Chest is an image analysis CAD software used during the review of digital chest radiographic images. | EDDA TECHNOLOGY | EDDA TECHNOLOGY, INC. | |
| 24 | 00866994000248 | 3.18 | eRAD RIS v3.2018 | eRAD RIS | ERAD, INC. | |
| 25 | 00866994000231 | 2.16 | eRAD RIS v2.2016 | eRAD RIS | ERAD, INC. | |
| 26 | 00866994000224 | 8.0 | eRAD PACS Evolution | eRAD PACS Evolution | ERAD, INC. | |
| 27 | 00866994000217 | 7.3 | eRAD PACS v7.3 | eRAD PACS | ERAD, INC. | |
| 28 | 00866994000200 | 7.2 | eRAD PACS v7.2 | eRAD PACS | ERAD, INC. | |
| 29 | 00866861000203 | 2.0 | The NDOHD system is intended for viewing, acquiring, recording, archiving and re The NDOHD system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic surgical procedures including, but not limited to, orthoscopic, gynecological, laparoscopic, urologic, sinuscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization. | NDOHD High Definition Imaging System (NDOHD) | ALTARAVISION, INC. | |
| 30 | 00866463000410 | 1.1 | 200003 | STAGE works as a comprehensive brain imaging post-processing solution. The STAGE STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available. | STAGE | SPINTECH, INC. |
| 31 | 00865936000285 | 3.8 | A medical image software package that aids the physician in the diagnosis of pat A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians. | MIMviewer | MIM SOFTWARE INC. | |
| 32 | 00865936000278 | 6.8 | A medical imaging software package that provide imaging solutions in the fields A medical imaging software package that provide imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging. | MIM | MIM SOFTWARE INC. | |
| 33 | 00865936000254 | 6.5 | A medical imaging software package that provides imaging solutions in the fields A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging. | MIM | MIM SOFTWARE INC. | |
| 34 | 00865936000247 | 3.7 | A medical image software package that aids the physician in the diagnosis of pat A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians. | MIMviewer | MIM SOFTWARE INC. | |
| 35 | 00865936000230 | 6.7 | A medical imaging software package that provides imaging solutions in the fields A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging. | MIM | MIM SOFTWARE INC. | |
| 36 | 00865936000223 | 3.6 | A medical image software package that aids the physician in the diagnosis of pat A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians. | MIMviewer | MIM SOFTWARE INC. | |
| 37 | 00865936000216 | 4.0 | A mobile medical imaging software package that is used for the viewing, registra A mobile medical imaging software package that is used for the viewing, registration, fusion, and/or display for diagnosis of medical images. It can be used to review images, contours, DVH, and isodose curves from radiation treatment plans. | Mobile MIM | MIM SOFTWARE INC. | |
| 38 | 00865936000209 | 6.6 | A medical imaging software package that provides imaging solutions in the fields A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging. | MIM | MIM SOFTWARE INC. | |
| 39 | 00865885000206 | ShowCase Basic, ShowCase Premier | ShowCase Basic and Premier are software applications for viewing medical images. | SHOWCASE® | TRILLIUM TECHNOLOGY, INC. | |
| 40 | 00864974000257 | v2018 | Corridor4DM | INVIA LLC | ||
| 41 | 00864974000233 | v2017 | Corridor4DM | INVIA LLC | ||
| 42 | 00864974000226 | v2016 | Corridor4DM | INVIA LLC | ||
| 43 | 00864974000219 | v2015 | Corridor4DM | INVIA LLC | ||
| 44 | 00864974000202 | v2013 | Corridor4DM | INVIA LLC | ||
| 45 | 00864908000117 | PACS-SW | The Radlink Picture Archiving and Communication System (PACS) is an external ser The Radlink Picture Archiving and Communication System (PACS) is an external server for storage and retrieval of varying modality images and their corresponding information. | Radlink PACS | RADLINK, INC. | |
| 46 | 00864747000279 | 4.0.6 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware 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 | |
| 47 | 00864747000262 | 4.0.4 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware 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 | |
| 48 | 00864747000255 | 4.0.3 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware 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 | |
| 49 | 00864747000248 | 4.0.2 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware 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 | |
| 50 | 00864747000231 | 3.0.0 | NeoSoft’s CAKE product is a post-processing, productivity software package desig NeoSoft’s CAKE product is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic breast MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.The results may be displayed as either a grayscale enhancement or a color overlay on the selected image. CAKE may perform additional functions to aid in the analysis and viewing of dynamic studies including registration of serial MR acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multi-planar reformats, maximum intensity projections, image averaging, and subtractions.When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CAKE analysis. | CAKE | NEOSOFT LLC |