| 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 | 00842000100027 | 9.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 3 | 00842000100010 | 10.0.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 4 | 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 | |
| 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 | 04560141950382 | V1.94R00E | ImagePilot | KONICA MINOLTA, INC. | ||
| 2 | 04560141949584 | V1.93R00E | ImagePilot | KONICA MINOLTA, INC. | ||
| 3 | 04560141949492 | V1.92R00E | ImagePilot | KONICA MINOLTA, INC. | ||
| 4 | 04560141947788 | ACDY | KONICAMINOLTA DI-X1 | KONICA MINOLTA, INC. | ||
| 5 | 04560141947771 | ACDX | KONICAMINOLTA DI-X1 | KONICA MINOLTA, INC. | ||
| 6 | 04560141945166 | A4C1 | CS-7 | KONICA MINOLTA, INC. | ||
| 7 | 04560141944961 | D9MA | ImagePilot | KONICA MINOLTA, INC. | ||
| 8 | 04548213030804 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 9 | 04548213026982 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 10 | 04548213026975 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 11 | 04548213026968 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 12 | 04548213026951 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 13 | 04548213026944 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 14 | 04548213026852 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 15 | 04548213026845 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 16 | 04548213026838 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 17 | 04548213026821 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 18 | 04548213026814 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 19 | 04548213026807 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 20 | 04548213026791 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 21 | 04548213026784 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 22 | 04548213026777 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 23 | 04548213026760 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 24 | 04548213025299 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 25 | 04548213025282 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 26 | 04548213025183 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 27 | 04548213025176 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 28 | 04548213024735 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 29 | 04548213024728 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 30 | 04548213024711 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 31 | 04548213024704 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 32 | 04548213024698 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
| 33 | 04547410345438 | MIS-1000 | ASPIRE Bellus II is medical imaging software that is intended to provide trained ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc. | ASPIRE Bellus II | FUJIFILM CORPORATION | |
| 34 | 04547410333527 | DR-ID800CL | The Console is a workstation intended to associate digital (for DR) images with The Console is a workstation intended to associate digital (for DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. | DR-ID800CL | FUJIFILM CORPORATION | |
| 35 | 04547410324877 | Synapse 3D | The product “Synapse 3D Base Tools” is a system that receives and retrieves DICO The product “Synapse 3D Base Tools” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis. | Synapse 3D | FUJIFILM CORPORATION | |
| 36 | 04547410316926 | CR-VW674 | FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patie FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR Viewcan receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images. | FCRView | FUJIFILM CORPORATION | |
| 37 | 04547410316872 | DR-ID900CL | The DR-ID 900CL is a workstation intended to associate digital (for CR and/or DR The DR-ID 900CL is a workstation intended to associate digital (for CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. | DR-ID900CL | FUJIFILM CORPORATION | |
| 38 | 04547410316865 | DR-ID300CL | The Console Advance is a workstation intended to associate digital (for CR and/o The Console Advance is a workstation intended to associate digital (for CR and/or DR) images. with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. | FDXConsole | FUJIFILM CORPORATION | |
| 39 | 04540217011469 | 502-24400-12 | DAR-8000i | SHIMADZU CORPORATION | ||
| 40 | 04540217011452 | 502-24400-11 | DAR-8000i | SHIMADZU CORPORATION | ||
| 41 | 04260648620022 | 2021 (Build 1920) | Ashvins | MEDICALCOMMUNICATIONS GMBH | ||
| 42 | 04260648620015 | 2.5 | Ashvins variant HEYEX 2 / HEYEX PACS | MEDICALCOMMUNICATIONS GMBH | ||
| 43 | 04260648620008 | Ashvins 2020 | Ashvins variant Diagnostic Workstation, Ashvins variant Image & Web Management | MEDICALCOMMUNICATIONS GMBH | ||
| 44 | 04260632470039 | 5.3 | Version 5.3 includes all minor versions and patch levels of 5.3 | JiveX | VISUS HEALTH IT GMBH | |
| 45 | 04260632470022 | 5.2 | Version 5.2 includes all minor versions and patch levels of 5.2 | JiveX | VISUS HEALTH IT GMBH | |
| 46 | 04260632470015 | 5.1 | Version 5.1 includes all minor versions and patch levels of 5.1 | JiveX | VISUS HEALTH IT GMBH | |
| 47 | 04260521365019 | 3.0 Galway | exoplan is a medical software, intended to support the pre-operative planning of exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides. | exoplan | EXOCAD GMBH | |
| 48 | 04260521365002 | 2.3 Matera | exoplan is a medical software, intended to support the pre-operative planning of exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal.exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions.The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides. | exoplan | EXOCAD GMBH | |
| 49 | 04260495880389 | 3.8.0 | The product mint Lesion helps qualified radiologists with the image-based diagno The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients.mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate.mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)).mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications. | mintLesion™ | MINT MEDICAL GMBH | |
| 50 | 04260495880372 | 3.7.0 | The product mint Lesion helps qualified radiologists with the image-based diagno The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients. mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate. mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)). mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications. | mintLesion® | MINT MEDICAL GMBH |