| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B109OPENSIGHT188040 | OpenSight 1.8804 | OpenSight is the combination of augmented reality glasses and Novarad's medical OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. | LLZ | System, Image Processing, Radiological | 2 | OpenSight | |
| 2 | B109OPENSIGHT187060 | OpenSight 1.8706 | OpenSight is the combination of augmented reality glasses and Novarad's medical OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. | LLZ | System, Image Processing, Radiological | 2 | OpenSight | |
| 3 | B109OPENSIGHT180760 | OpenSight 1.8076 | OpenSight is the combination of augmented reality glasses and Novarad's medical OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. | LLZ | System, Image Processing, Radiological | 2 | OpenSight | |
| 4 | B109NOVAPACS8930 | NovaPACS 8.9.3 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 5 | B109NOVAPACS8920 | NovaPACS 8.9.2 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 6 | B109NOVAPACS8910 | NovaPACS 8.9.1 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 7 | B109NOVAPACS8850 | NovaPACS 8.8.5 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 8 | B109NOVAPACS8840 | NovaPACS 8.8.4 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 9 | B109NOVAPACS8830 | NovaPACS 8.8.3 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 10 | B109NOVAPACS8780 | NovaPACS 8.7.8 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 11 | B109NOVAPACS8770 | NovaPACS 8.7.7 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 12 | B109NOVAPACS8760 | NovaPACS 8.7.6 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 13 | B109NOVAPACS8740 | NovaPACS 8.7.4 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 14 | B109NOVAPACS87110 | NovaPACS 8.7.11 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 15 | B109NOVAPACS8690 | NovaPACS 8.6.9 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 16 | B109NOVAPACS8680 | NovaPACS 8.6.8 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 17 | B109NOVAPACS8670 | NovaPACS 8.6.7 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 18 | B109NOVAPACS8660 | NovaPACS 8.6.6 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 19 | B109NOVAPACS8650 | NovaPACS 8.6.5 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 20 | B109NOVAPACS8640 | NovaPACS 8.6.4 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 21 | B109NOVAPACS8630 | NovaPACS 8.6.3 | A picture and communication system software that retrieves, archives, distribute A picture and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 22 | B109NOVAPACS86140 | NovaPACS 8.6.14 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 23 | B109NOVAPACS86110 | NovaPACS 8.6.11 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 24 | B109NOVAPACS8610 | NovaPACS 8.6.1 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 25 | B109NOVAPACS85190 | NovaPACS 8.5.19 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 26 | B109NOVAPACS85180 | NovaPACS 8.5.18 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 27 | B109NOVAPACS85170 | NovaPACS 8.5.17 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 28 | B109NOVAPACS85160 | NovaPACS 8.5.16 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 29 | B109NOVAPACS85150 | NovaPACS 8.5.15 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 30 | B109NOVAPACS85140 | NovaPACS 8.5.14 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 31 | B109NOVAPACS85120 | NovaPACS 8.5.12 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS | |
| 32 | B109NOVAPACS8590 | NovaPACS 8.5.9 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS™ | |
| 33 | B109NOVAPACS8580 | NovaPACS 8.5.8 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS™ | |
| 34 | B109NOVAPACS8570 | NovaPACS 8.5.7 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS™ | |
| 35 | B109NOVAPACS8560 | NovaPACS 8.5.6 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS™ | |
| 36 | B109NOVAPACS85110 | NovaPACS 8.5.11 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS™ | |
| 37 | B109NOVAPACS85100 | NovaPACS 8.5.10 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | LLZ | System, Image Processing, Radiological | 2 | NovaPACS™ | |
| 38 | B109NOVAMG1860 | NovaMG 1.8.6 | NovaPACS is a picture archiving and communication system software that retrieves NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS contains WorkstationOne software developed by Three Palm Software and branded as NovaMG with WorkstationOne for softcopy reading and interpretation of digital mammography images by Radiologists. | LLZ | System, Image Processing, Radiological | 2 | NovaMG | |
| 39 | B109NOVAMG1840 | NovaMG 1.8.4 | NovaPACS is a picture archiving and communication system software that retrieves NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS contains WorkstationOne software developed by Three Palm Software and branded as NovaMG with WorkstationOne for softcopy reading and interpretation of digital mammography images by Radiologists. | LLZ | System, Image Processing, Radiological | 2 | NovaMG | |
| 40 | B109NOVAMG1820 | NovaMG 1.8.2 | NovaPACS™ is a picture archiving and communication system software that retrieve NovaPACS™ is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS™ contains WorkstationOne™ software developed by Three Palm Software and branded as NovaMG™ with WorkstationOne™ for softcopy reading and interpretation of digital mammography images by Radiologists. | LLZ | System, Image Processing, Radiological | 2 | NovaMG™ |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 | |
| 2 | 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 | |
| 3 | 04260495880365 | 3.6.0 | 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 | |
| 4 | 04260495880358 | 3.5.0 | 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 | |
| 5 | 04260495880341 | 3.4.0 | 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 | |
| 6 | 04260483290183 | 2.4 | 2.4.0.229939, Release date: 2021-09-032.4.1.252491, Release date: 2022-03-25 | DynaCAD Lung | MEVIS MEDICAL SOLUTIONS AG | |
| 7 | 04260483290176 | 1.7 | 1.7.0.228241, Release date: 2021-03-181.7.1.252491, Release date: 2022-03-25 | Veolity | MEVIS MEDICAL SOLUTIONS AG | |
| 8 | 04260483290169 | 3.2 | DynaSuite Neuro | MEVIS MEDICAL SOLUTIONS AG | ||
| 9 | 04260483290114 | 2.3 | DynaCAD Lung | MEVIS MEDICAL SOLUTIONS AG | ||
| 10 | 04260483290091 | 1.4 | Veolity | MEVIS MEDICAL SOLUTIONS AG | ||
| 11 | 04260483290077 | 3.1 | DynaSuite Neuro | MEVIS MEDICAL SOLUTIONS AG | ||
| 12 | 04260483290053 | 2.2 | DynaCAD Lung | MEVIS MEDICAL SOLUTIONS AG | ||
| 13 | 04260483290039 | 1.3 | Veolity | MEVIS MEDICAL SOLUTIONS AG | ||
| 14 | 04260476810015 | 3 | Software for biopsy needle guide planning and tracking. | BioJet Target | MEDICAL TARGETING TECHNOLOGIES GMBH | |
| 15 | 04260476510038 | v1 (US) | aycan mobile | AYCAN DIGITALSYSTEME GMBH | ||
| 16 | 04260476510021 | v3 | aycan workstation | AYCAN DIGITALSYSTEME GMBH | ||
| 17 | 04260456230147 | 4.80.0 | CHILI PACS is a picture archiving and communication system with image processing CHILI PACS is a picture archiving and communication system with image processing functions to support physicians in diagnosis and treatment planning. | CHILI PACS | CHILI GMBH | |
| 18 | 04260456230130 | 4.78.0 | CHILI PACS | CHILI GMBH | ||
| 19 | 04260456230123 | 4.76.0 | CHILI PACS | CHILI PACS | CHILI GMBH | |
| 20 | 04260456230116 | 4.74.0 | CHILI PACS | CHILI GMBH | ||
| 21 | 04260456230109 | 4.72.0 | CHILI PACS | CHILI GMBH | ||
| 22 | 04260456230093 | 4.70.0 | CHILI PACS | CHILI PACS | CHILI GMBH | |
| 23 | 04260456230086 | 4.68.0 | CHILI PACS 4.68.0 | CHILI PACS | CHILI GMBH | |
| 24 | 04260456230079 | 4.66.0 | CHILI PACS 4.66.0 | CHILI PACS | CHILI GMBH | |
| 25 | 04260456230062 | 4.64.0 | CHILI PACS 4.64.0 | CHILI PACS | CHILI GMBH | |
| 26 | 04260456230055 | 4.62.0 | CHILI PACS 4.62.0 | CHILI PACS | CHILI GMBH | |
| 27 | 04260456230048 | 4.60 | CHILI GmbH | CHILI GMBH | ||
| 28 | 04260456230031 | 4.58 | CHILI PACS 4.58 | CHILI PACS | CHILI GMBH | |
| 29 | 04260456230024 | 4.56 | CHILI PACS 4.56 | CHILI PACS | CHILI GMBH | |
| 30 | 04260456230017 | 4.54 | CHILI PACS 4.54 | CHILI PACS | CHILI GMBH | |
| 31 | 04260456230000 | 4.52 | CHILI PACS 4.52 | CHILI PACS | CHILI GMBH | |
| 32 | G090AIM11 | 1 | AIM1 | AI Metrics is a thin client software application used with general purpose compu AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including: • Manual annotation tools for users to select regions of interest (ROIs), • Semi-automatic lesion segmentation suggestions for user-selected ROIs, • Automatic measurement and display of long and short axis of segmented lesions, • Automatic tabulation and summation of measurements,• Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality), • Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and • Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report. | AI Metrics | AI METRICS, LLC |
| 33 | G01900 | 06 | ThinkingNet | THINKING SYSTEMS CORPORATION | ||
| 34 | G003DM01 | 1 | 3D printed patient specific replicas of patient anatomy | 3D Anatomic Model | RICOH USA, INC. | |
| 35 | EOLEOLEASPHEREV3P01 | 3.0 | Olea Sphere V3.0 is an image processing software package to be used by trained p Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
| 36 | EOLEOLEASPHEREV2P31 | 2.3 | Olea Sphere V2.3 is an image processing software package to be used by trained p Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
| 37 | EOLEFMRIV1P00 | V1.0 | Functional MR V1.0 is an optional image processing software application that is Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers.Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis.Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. | FUNCTIONAL MR | OLEA MEDICAL USA | |
| 38 | EOLEBREASTSCAPEV1P00 | V1.0 | breastscape V1.0 is an optional image processing software application that is in breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists.breastscape V1.0 includes 2 software modules :- BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis.- BreastLoc to assist users in planning MR guided breast interventional procedures.Data and images are acquired through DICOM compliant imaging devices and modalities. | BREASTSCAPE | OLEA MEDICAL USA | |
| 39 | 04260361440204 | TTA2.51 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 40 | 04260361440198 | TTA2.42 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 41 | 04260361440181 | TTA2.50 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 42 | 04260361440174 | TTA2.41 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 43 | 04260361440167 | TTA2.40 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images.Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 44 | 04260361440150 | IA4 | The IMAGE-ARENA software platform is intended to import, export, store, retrieve The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool.IMAGE-ARENA is not intended to be used for reading of mammography images. | IMAGE-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 45 | 04260361440143 | TTA2 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 46 | 04251332920023 | 1.12 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 47 | 04251332920016 | 1.10 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 48 | 04251332920009 | 1.8.2 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 49 | 04251332910079 | 7.1.17 | Visage 7 | VISAGE IMAGING GMBH | ||
| 50 | 04251332910062 | 7.1.16 | Visage 7 | VISAGE IMAGING GMBH |