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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 Class Implantable

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MU2net - B501MU2NET020101

MU2net is a standalone software device designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems.
DOSISOFT
2.1.1
In Commercial Distribution

  • B501MU2NET020101 ()
2.1.1

  • Radiation therapy software

EPIgray - B501EPIGRAY020010

Radiotherapy quality assurance software tool.
DOSISOFT
2.0.10
In Commercial Distribution

  • B501EPIGRAY020010 ()
EP1001

  • Radiation therapy software

EPIgray - B501EPIGRAY020007

Radiotherapy software quality assurance tool
DOSISOFT
2.0.7
In Commercial Distribution

  • B501EPIGRAY020007 ()
2.0.7

  • Radiation therapy software

EPIgray - B501EPIGRAY020006

Radiotherapy software quality assurance tool.
DOSISOFT
2.0.6
In Commercial Distribution

  • B501EPIGRAY020006 ()
2.0.6

  • Radiation therapy software

Odyssey - B211ODY520106

Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be exported in DICOM formats to administer treatments after review and approval by the intended user.
PERMEDICS INC
5.2.01
In Commercial Distribution

  • B211ODY520106 ()


  • Radiation therapy software

Odyssey - B211ODY520005

Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be exported in DICOM formats to administer treatments after review and approval by the intended user.
PERMEDICS INC
5.2.00
In Commercial Distribution

  • B211ODY520005 ()


  • Radiation therapy software

InsightRT Software Suite Server - B244ISS100S0

No Description
SIRIS MEDICAL, INC.
ISS100S
Not in Commercial Distribution

  • B244ISS100S0 ()
ISS100S

  • Radiation therapy software

InsightRT CDS - B244IRT1000

No Description
SIRIS MEDICAL, INC.
IRT100
In Commercial Distribution

  • B244IRT1000 ()
IRT100

  • Radiation therapy software

Vision RT - B120ALIGNRT0

No Description
VISION RT LIMITED
AlignRT
Not in Commercial Distribution

  • B120ALIGNRT0 ()
AlignRT

  • Radiological video camera patient positioning/tracking system

System 2100 - B229S210011

No Description
MATH RESOLUTIONS, LLC
1
In Commercial Distribution

  • B229S210011 ()


  • Radiation therapy software
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