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ORTHONOL(R) PREFORM NATURAL ARCH MX .017 X .025 34MM
Rmo, Inc.
A07075
In Commercial Distribution
- 00000008857972 ()
- 00885797019837 ()
- Orthodontic archwire
No Description
Prowess, Inc.
v5.61
In Commercial Distribution
- 00859032007088 ()
- Radiation therapy software
ULTRASOUND DATA ANALYSIS SYSTEM
FUJIFILM HEALTHCARE CORPORATION
DAS-RS1
- 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
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
AVEA NIMV+VG SW KEY
VYAIRE MEDICAL, INC.
63865
In Commercial Distribution
- 10190752175921 ()
63865
- Ventilator application software
No Description
Zetta25 AG
04262352359243
In Commercial Distribution
- 04262352359243 ()
- CAD/CAM software
DI Scan
Zetta25 AG
04262352350035
In Commercial Distribution
- 04262352350035 ()
S3806
- CAD/CAM software
AIRAscore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
AIRAmed GmbH
v2.4.0
In Commercial Distribution
- 04260723680040 ()
- Radiological PACS software
No Description
MedicalCommunications GmbH
2.6.5 (Build 2167)
In Commercial Distribution
- 04260648620060 ()
- Ophthalmology PACS software
No Description
MedicalCommunications GmbH
2.5
In Commercial Distribution
- 04260648620015 ()
- Ophthalmology PACS software
Version 5.4+ includes all minor versions and patch levels of 5.4 as well as higher versions (e.g. 5.5) in case no new 510(k) submission is needed.
VISUS Health IT GmbH
5.4+
In Commercial Distribution
- 04260632470084 ()
- Radiological PACS software
Version 5.3 includes all minor versions and patch levels of 5.3
VISUS Health IT GmbH
5.3
Not in Commercial Distribution
- 04260632470039 ()
- Radiological PACS software
Version 5.2 includes all minor versions and patch levels of 5.2
VISUS Health IT GmbH
5.2
Not in Commercial Distribution
- 04260632470022 ()
- Radiological PACS software
Version 5.1 includes all minor versions and patch levels of 5.1
VISUS Health IT GmbH
5.1
Not in Commercial Distribution
- 04260632470015 ()
- 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