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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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NA - 08717213051782

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-04
Not in Commercial Distribution

  • 08717213051782 ()


  • Radiation therapy software

NA - 08717213051775

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-23
Not in Commercial Distribution

  • 08717213051775 ()


  • Radiation therapy software

NA - 08717213051294

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170730
Not in Commercial Distribution

  • 08717213051294 ()


  • Radiation therapy software

Radiation Planning Assistant (RPA) - 00040695000008

The Radiation Planning Assistant (RPA) is a web-based contouring and radiotherapy treatment planning software tool that incorporates the basic radiation planning functions from automated contouring, automated planning with dose optimization, and quality control checks. The system is intended for use for patients with cancer of the head and neck, cervix, breast, and metastases to the brain. The RPA system is integrated with the Eclipse Treatment Planning System v15.6 software cleared under K181145. The RPA radiation treatment planning software tool was trained against hundreds / thousands of CT Scans of normal and diseased tissues from patients receiving radiation for head and neck, cervical, breast, and whole brain at MD Anderson Cancer Center.
The University of Texas M. D. Anderson Cancer Center
1.0.0.5
In Commercial Distribution

  • 00040695000008 ()


  • Radiation therapy software

3DIEMME RealGUIDE - 08050038830058

Full integrated planning, guide design and prosthesis modelling
3DIEMME SRL
RealGUIDE CAD+
In Commercial Distribution

  • 08050038830058 ()


  • CAD/CAM software

3DIEMME RealGUIDE - 08050038830041

Prosthesis modelling (stand-alone)
3DIEMME SRL
RealGUIDE CAD
In Commercial Distribution

  • 08050038830041 ()


  • CAD/CAM software

3DIEMME RealGUIDE - 08050038830034

3D diagnosis and communication module
3DIEMME SRL
RealGUIDE START
In Commercial Distribution

  • 08050038830034 ()


  • CAD/CAM software

3DIEMME RealGUIDE - 08050038830027

Surgical guides modelling
3DIEMME SRL
RealGUIDE DESIGN
In Commercial Distribution

  • 08050038830027 ()


  • CAD/CAM software

3DIEMME RealGUIDE - 08050038830010

Implants planning
3DIEMME SRL
RealGUIDE PRO
In Commercial Distribution

  • 08050038830010 ()


  • CAD/CAM software

3DIEMME RealGUIDE - 08050038830003

Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
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