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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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No Description
VISION RT LIMITED
Power Supply Unit (PSU)
In Commercial Distribution

  • 05056190500061 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Real Time Coach
In Commercial Distribution

  • 05056190500054 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Head Adjuster
In Commercial Distribution

  • 05056190500047 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
AlignRT Offline
Not in Commercial Distribution

  • 05056190500030 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
GateCT
In Commercial Distribution

  • 05056190500023 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
GateRT
In Commercial Distribution

  • 05056190500016 ()


  • Radiological video camera patient positioning/tracking system
AlignRT system
VISION RT LIMITED
AlignRT 5.x 115V or 230V
In Commercial Distribution

  • 05056190500009 ()


  • Radiological video camera patient positioning/tracking system
Radiation therapy QA software.
SUN NUCLEAR CORP.
1216028
In Commercial Distribution

1216028

  • Radiation therapy software
SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data. SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department’s QA efforts.
SUN NUCLEAR CORP.
1299028
In Commercial Distribution

  • 05060608880348 ()
1299000-0

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

  • 00860004284901 ()


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

  • 00860001672701 ()


  • 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
The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatment planning. This includes computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides data in the form of display, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. Panther treatment planning system allows radiation physicians, physicists, and dosimetrists to optimize the delivery of radiation in treating cancer and related diseases.
Prowess, Inc.
version 5.51
Not in Commercial Distribution

  • 00868603000236 ()


  • Radiation therapy software
The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363056 ()

  • Height: 700 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system
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