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No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution
- 00899475002417 ()
- Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution
- 00899475002400 ()
- Radiation therapy software
Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud.
SONOMED, INC.
Ver 5
In Commercial Distribution
- 00896100002002 ()
Axis
- Ophthalmology PACS software
Radiance V4 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V4 shall be clinically qualified radiation therapy staff trained in using the system.
GMV SOLUCIONES GLOBALES INTERNET SA
4
In Commercial Distribution
- 08436567540017 ()
- Radiation therapy software
Radiance V3 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system.
GMV SOLUCIONES GLOBALES INTERNET SA
3
In Commercial Distribution
- 08436567540000 ()
- Radiation therapy software
LIFESYS PACS v2
LIFETRACK MEDICAL SYSTEMS INC.
2
In Commercial Distribution
- B581LIFESYSPACSV20 ()
- Radiological PACS software
No Description
Orthosoft Inc
803.3020
In Commercial Distribution
- 00889024211629 ()
803.3020
- CAD/CAM software
No Description
Orthosoft Inc
305.1004
Not in Commercial Distribution
- 00889024211612 ()
305.1004
- CAD/CAM software
ALLEGRETTO WAVE EYE-Q EXCIMER
Alcon Laboratories, Inc.
8065990817
Not in Commercial Distribution
- 00380659908170 ()
8065990817
- Laser application software
SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.
SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH).
BEBIG Medical GmbH
06
In Commercial Distribution
- 04065983000047 ()
1374-0610
- Radiation therapy software
SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.
SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH).
BEBIG Medical GmbH
06
In Commercial Distribution
- 04065983000016 ()
1374-0600
- Radiation therapy software
No Description
SAMSUNG MEDISON CO., LTD.
USO-U0N5B0K/WR
In Commercial Distribution
- 08806167789466 ()
- Radiological PACS software
No Description
SAMSUNG MEDISON CO., LTD.
USO-U0N5B0B/WR
In Commercial Distribution
- 08806167761172 ()
- Radiological PACS software
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.
Mint Medical GmbH
3.8.0
In Commercial Distribution
- 04260495880389 ()
- Radiological PACS software
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.
Mint Medical GmbH
3.7.0
In Commercial Distribution
- 04260495880372 ()
- Radiological PACS software
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.
Mint Medical GmbH
3.6.0
- Radiological PACS software
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.
Mint Medical GmbH
3.5.0
- Radiological PACS software
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.
Mint Medical GmbH
3.4.0
- Radiological PACS software
No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.5
In Commercial Distribution
- 09421904268333 ()
- Radiological PACS software
Volpara Density Map 4.0
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.0
In Commercial Distribution
- 09421904268319 ()
- Radiological PACS software
Volpara Density Map 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution
- 09421904268289 ()
- Radiological PACS software
VolparaDensity 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution
- 09421904268258 ()
- Radiological PACS software
No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.0
In Commercial Distribution
- 09421904268241 ()
- Radiological PACS software
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 Imaging Systems GmbH
TTA2.52
In Commercial Distribution
- 04260361440211 ()
- Radiological PACS software
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 Imaging Systems GmbH
TTA2.51
In Commercial Distribution
- 04260361440204 ()
- Radiological PACS software
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 Imaging Systems GmbH
TTA2.42
In Commercial Distribution
- 04260361440198 ()
- Radiological PACS software
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 Imaging Systems GmbH
TTA2.50
In Commercial Distribution
- 04260361440181 ()
- Radiological PACS software
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 Imaging Systems GmbH
TTA2.41
In Commercial Distribution
- 04260361440174 ()
- Radiological PACS software
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 Imaging Systems GmbH
TTA2.40
Not in Commercial Distribution
- 04260361440167 ()
- Radiological PACS software
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.
TOMTEC Imaging Systems GmbH
IA4
Not in Commercial Distribution
- 04260361440150 ()
- Radiological PACS software
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 Imaging Systems GmbH
TTA2
In Commercial Distribution
- 04260361440143 ()
- Radiological PACS software
The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device.
It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device.
The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. EBRT
In Commercial Distribution
- 04260308110108 ()
- Radiation therapy software
The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device.
It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device.
The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. IORT
- Radiation therapy software
The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron.
It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device.
The machine parameters are not intended to be used for direct control for the radiation device.
Machine Output Quality can be visualized and recorded over time for quality assurance.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1.
In Commercial Distribution
- 04260308110078 ()
- Radiation therapy software
No Description
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
1.8
In Commercial Distribution
- 04260308110023 ()
- Radiation therapy software
INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution
- 09420012424990 ()
900SW100
- Ventilator application software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.3
In Commercial Distribution
- 09358140000048 ()
SCI0001
- Radiological PACS software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.2
In Commercial Distribution
- 09358140000024 ()
SCI0001
- Radiological PACS software
No Description
Omniscient Neurotechnology Pty Ltd (o8t)
1.1
In Commercial Distribution
- 09358140000017 ()
SCI0001
- Radiological PACS software
The overall intended use of neotivCare is to provide an app-based objective measurement of cognition to quantify cognitive impairment. The software is intended for use by patients at the indication of medical professionals to quantify and monitor a suspected or self-reported cognitive impairment. The app is not intended as a standalone diagnostic assessment and is only indicated as a tool to support the diagnostic process of a medical professional.
neotiv GmbH
1.0.0
In Commercial Distribution
- 04262390860015 ()
- Cognitive assessment software
No Description
Visage Imaging GmbH
7.1.14
In Commercial Distribution
- 04251332910048 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
7.1.11
In Commercial Distribution
- 04251332910024 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
7.1.9
In Commercial Distribution
- 04251332910000 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
2.2
In Commercial Distribution
- 04251332920047 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
2.0
In Commercial Distribution
- 04251332920030 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
1.12
In Commercial Distribution
- 04251332920023 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
1.10
In Commercial Distribution
- 04251332920016 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
1.8.2
In Commercial Distribution
- 04251332920009 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
7.1.19
In Commercial Distribution
- 04251332910093 ()
- Radiological PACS software
No Description
Visage Imaging GmbH
7.1.18
In Commercial Distribution
- 04251332910086 ()
- Radiological PACS software