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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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2MP Monochrome LCD Monitor
EIZO CORPORATION
GX240
In Commercial Distribution

  • 14995047061219 ()
  • 04995047061212 ()
  • 04995047040217 ()
GX240-CL-BK-P

  • Image display unit, monochrome
2MP Monochrome LCD Monitor
EIZO CORPORATION
GX240
In Commercial Distribution

GX240-CL-BK

  • Image display unit, monochrome
3MP Monochrome LCD Monitor
EIZO CORPORATION
GX340
In Commercial Distribution

  • 14995047061110 ()
  • 04995047061113 ()
  • 04995047040255 ()
GX340-CL-BK-P

  • Image display unit, monochrome
3MP Monochrome LCD Monitor
EIZO CORPORATION
GX340
In Commercial Distribution

GX340-CL-BK

  • Image display unit, monochrome
Enterprise Imaging XERO Viewer 8.x
Agfa HealthCare NV
8
In Commercial Distribution



  • Radiological PACS software
Enterprise Imaging Desktops 8.x
Agfa HealthCare NV
8
In Commercial Distribution



  • Radiological PACS software
IMPAX Software 6.X
Agfa HealthCare NV
6
In Commercial Distribution



  • Radiological PACS software
ULTRASOUND DATA ANALYSIS SYSTEM
FUJIFILM HEALTHCARE CORPORATION
DAS-RS1
In Commercial Distribution



  • Radiological PACS software
No Description
Change Healthcare Canada Company
12.3
In Commercial Distribution



  • 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
In Commercial Distribution



  • Radiological PACS software
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