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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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ClearCheck is intended for quality assessment of radiotherapy treatment plans.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672701 ()


  • Radiation therapy software
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
STANDARD IMAGING INC.
v5
In Commercial Distribution

  • 00866562000236 ()
91309

  • Radiation therapy software
Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.
STANDARD IMAGING INC.
v3
In Commercial Distribution

  • 00866562000229 ()
91326

  • Radiation therapy software
MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc.
Oncology Data Systems Inc
MUCheck®
In Commercial Distribution

  • 00860175002403 ()


  • Radiation therapy software
No Description
Oncospace, Inc.
System
In Commercial Distribution

  • 00860004284901 ()


  • Radiation therapy software
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 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 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
No Description
Elekta Solutions AB
3.0.2
In Commercial Distribution

  • 00858164002381 ()


  • Radiation therapy software
No Description
Elekta Solutions AB
Monaco
In Commercial Distribution

  • 00858164002275 ()


  • Radiation therapy software
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