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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 Class Implantable

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3D Brachy Application - 00860007402326

3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402326 ()


  • Radiation therapy software

3D Bolus Application - 00860007402319

3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402319 ()


  • Radiation therapy software

3D Bolus Software - 00860007402302

3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
Adaptiiv Medical Technologies Inc
v3.0.0
In Commercial Distribution

  • 00860007402302 ()


  • Radiation therapy software

Aqua - 00858164002381

No Description
Elekta Solutions AB
3.0.2
In Commercial Distribution

  • 00858164002381 ()


  • Radiation therapy software

Monaco - 00858164002275

No Description
Elekta Solutions AB
Monaco
In Commercial Distribution

  • 00858164002275 ()


  • Radiation therapy software

Monaco - 00858164002268

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002268 ()


  • Radiation therapy software

Monaco - 00858164002244

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002244 ()


  • Radiation therapy software

ERGO Localizer - 00858164002213

No Description
ELEKTA, INC.
ERGO Localizer
Not in Commercial Distribution

  • 00858164002213 ()


  • Radiation therapy software

ERGO++ - 00858164002206

No Description
ELEKTA, INC.
ERGO++
Not in Commercial Distribution

  • 00858164002206 ()


  • Radiation therapy software

Monaco - 00858164002190

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002190 ()


  • Radiation therapy software
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