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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 (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
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa 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.
RADIALOGICA LLC
1.x
In Commercial Distribution

  • 00863284000315 ()


  • Radiation therapy software
RadCalc® #1 Trusted Dosimetric Verification Software. RadCalc Software. LifeLine Software, Inc.
LIFELINE SOFTWARE INC
RadCalc®
In Commercial Distribution

  • 00867520000206 ()


  • Radiation therapy software
Standard Imaging QA Pilot is cloud-based software tool that allows users to enter, store, and analyze data accumulated in the clinical radiation oncology setting from quality assurance processes.
STANDARD IMAGING INC.
91348
In Commercial Distribution

  • 00866562000298 ()
91348

  • Radiation therapy software
Standard Imaging RAy Software is a film dosimetry application, designed to perform one-dimensional, two-dimensional, and three-dimensional analyses of dose deposition pattern on film under specific mega-voltage irradiation setups.
STANDARD IMAGING INC.
91336
In Commercial Distribution

  • 00866562000274 ()
91336

  • Radiation therapy software
Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems.
STANDARD IMAGING INC.
91330
In Commercial Distribution

  • 00866562000267 ()
91330

  • Radiation therapy software
Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems.
STANDARD IMAGING INC.
v1
In Commercial Distribution

  • 00866562000243 ()
91350

  • 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
The Radiation Analyzer (RAy)is a film dosimetry application used to verify complex radiation therapy treatment plans.
AGILE RADIOLOGICAL TECHNOLOGIES
5.0
Not in Commercial Distribution

  • 00866498000300 ()
Ray 5.0

  • Radiation therapy software
SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH).
BEBIG Medical GmbH
06
In Commercial Distribution

  • 04065983000047 ()
1374-0610

  • Radiation therapy software
SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH).
BEBIG Medical GmbH
06
In Commercial Distribution

  • 04065983000016 ()
1374-0600

  • Radiation therapy software
No Description
Brainlab AG
4.5
In Commercial Distribution

  • 04056481146030 ()


  • Radiation therapy software
No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481144609 ()


  • Radiation therapy software
No Description
Brainlab AG
4.0
In Commercial Distribution

  • 04056481144494 ()


  • Radiation therapy software
No Description
Brainlab AG
1.1
In Commercial Distribution

  • 04056481143978 ()


  • Radiation therapy software
No Description
Brainlab AG
3.0
In Commercial Distribution

  • 04056481142131 ()


  • Radiation therapy software
No Description
Brainlab AG
3.0
In Commercial Distribution

  • 04056481142124 ()


  • Radiation therapy software
No Description
Brainlab AG
3.0
In Commercial Distribution

  • 04056481142117 ()


  • Radiation therapy software
No Description
Brainlab AG
3.0
In Commercial Distribution

  • 04056481142100 ()


  • Radiation therapy software
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