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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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Standard Imaging IMSure 3D - 00850019946543

Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
STANDARD IMAGING INC.
91365
In Commercial Distribution

  • 00850019946543 ()
91365

  • Radiation therapy software

FilmQA Pro - 00850000065000

Radiation/Radiology Software
ASHLAND SPECIALTY INGREDIENTS G.P.
7.0
In Commercial Distribution

  • 00850000065000 ()
N/A

  • Radiation therapy software

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

Oncospace - 00860004284901

No Description
Oncospace, Inc.
System
In Commercial Distribution

  • 00860004284901 ()


  • Radiation therapy software

ChartCheck - 00860001672749

ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imaging, and documentation data in a simple, web-based interface.
Radformation, Inc
1.2
In Commercial Distribution

  • 00860001672749 ()


  • Radiation therapy software

AutoContour - 00860001672732

AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672732 ()


  • Radiation therapy software

ClearCalc - 00860001672725

ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672725 ()


  • Radiation therapy software

EZFluence - 00860001672718

EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photo treatment fields.
Radformation, Inc
2.3
In Commercial Distribution

  • 00860001672718 ()


  • Radiation therapy software
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