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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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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
No Description
SiCAT GmbH & Co. KG
V2.0.40
In Commercial Distribution

  • D776IMPLANTV20400 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776IMPLANTV200 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V1.5
Not in Commercial Distribution

  • D776IMPLANTV15 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
1.9.2
Not in Commercial Distribution

  • D776GIV1920 ()
6143205

  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776FUNCTIONV200 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776FUNCTIONV20 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776ENDOV20 ()


  • Radiological PACS software
Radiological Visualization Software for Diagnosis and Dental Treatment Planning
SiCAT GmbH & Co. KG
6622463
Not in Commercial Distribution

  • D77666224630 ()
6622463

  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776SUITEV200 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776SUITEV20 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V1.5
Not in Commercial Distribution

  • D776IMPLANTV150 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0.40
In Commercial Distribution

  • D776FUNCTIONV20400 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0.40
In Commercial Distribution

  • D776ENDOV20400 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
V2.0
Not in Commercial Distribution

  • D776ENDOV200 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
2.0.40
In Commercial Distribution

  • D776AIRV20400 ()


  • Radiological PACS software
No Description
SiCAT GmbH & Co. KG
2.0
Not in Commercial Distribution

  • D776AIRV200 ()


  • Radiological PACS software
No Description
Ischemaview, Inc.
5.0.3
In Commercial Distribution

  • B7671R5030 ()


  • Radiological PACS software
No Description
Ischemaview, Inc.
5.1
In Commercial Distribution

  • B761RAPID510 ()
Rapid 5.1

  • Radiological PACS software
No Description
Ischemaview, Inc.
5.0.2
In Commercial Distribution

  • B761RAPID5020 ()


  • Radiological PACS software
Rapid
Ischemaview, Inc.
5.0
In Commercial Distribution

  • B761RAPID500 ()
Rapid

  • Radiological PACS software
RAPID is a Platform for brain image analysis.
Ischemaview, Inc.
4.8.3
In Commercial Distribution

  • B761RAPID48302 ()
RAPID

  • Radiological PACS software
Rapid System Update
Ischemaview, Inc.
5.7.2
In Commercial Distribution

  • B761R5721 ()
Rapid

  • Radiological PACS software
Rapid System Update
Ischemaview, Inc.
5.7
In Commercial Distribution

  • B761R5701 ()
Rapid

  • Radiological PACS software
Rapid System Update
Ischemaview, Inc.
5.5.1
In Commercial Distribution

  • B7615511 ()


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

  • 08050038830058 ()


  • CAD/CAM software
Prosthesis modelling (stand-alone)
3DIEMME SRL
RealGUIDE CAD
In Commercial Distribution

  • 08050038830041 ()


  • CAD/CAM software
3D diagnosis and communication module
3DIEMME SRL
RealGUIDE START
In Commercial Distribution

  • 08050038830034 ()


  • CAD/CAM software
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