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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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AccuCheck - 06973127400043

AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Manteia Technologies Co.,Ltd.
1.1
In Commercial Distribution

  • 06973127400043 ()


  • Radiation therapy software

MRI Planner - 07350097430017

MRI Planner is a stand alone software product intended to enable a completely MRI only workflow in radiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MR image and generating a synthetic CT image that can replace the conventional CT in the treatment planning process. In addition, the software also performs automated contouring of risk organs in certain anatomies. In the current version of MRI Planner, synthetic CT generation is supported for the brain, head-neck and pelvis anatomies, whereas automated risk organ contouring is supported for bladder, colon and femoral heads for prostate cancer patients only.
Spectronic Medical AB
2
In Commercial Distribution

  • 07350097430017 ()


  • Radiation therapy software

RayStation - 07350002010884

No Description
Raysearch Laboratories AB (Publ)
2024A SP3
In Commercial Distribution

  • 07350002010884 ()


  • Radiation therapy software

RayStation - 07350002010730

No Description
Raysearch Laboratories AB (Publ)
12A SP2
In Commercial Distribution

  • 07350002010730 ()


  • Radiation therapy software

RayStation - 07350002010679

No Description
Raysearch Laboratories AB (Publ)
12A SP1
In Commercial Distribution

  • 07350002010679 ()


  • Radiation therapy software

RayStation - 07350002010570

No Description
Raysearch Laboratories AB (Publ)
11B SPT1
In Commercial Distribution

  • 07350002010570 ()


  • Radiation therapy software

RayStation - 07350002010556

No Description
Raysearch Laboratories AB (Publ)
2023B
In Commercial Distribution

  • 07350002010556 ()


  • Radiation therapy software

RayStation - 07350002010549

No Description
Raysearch Laboratories AB (Publ)
12A
In Commercial Distribution

  • 07350002010549 ()


  • Radiation therapy software

RayStation - 07350002010501

No Description
Raysearch Laboratories AB (Publ)
11B SP2
In Commercial Distribution

  • 07350002010501 ()


  • Radiation therapy software

RayStation - 07350002010495

No Description
Raysearch Laboratories AB (Publ)
11B SP1
In Commercial Distribution

  • 07350002010495 ()


  • Radiation therapy software
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