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
AlignRT
Not in Commercial Distribution

  • B120ALIGNRT0 ()
AlignRT

  • Radiological video camera patient positioning/tracking system
Radiation/Radiology Software
ASHLAND SPECIALTY INGREDIENTS G.P.
8.0
In Commercial Distribution

  • 00810106410845 ()
987957

  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.8.X
In Commercial Distribution

  • 00628011382184 ()


  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.7.X
In Commercial Distribution

  • 00628011382177 ()


  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.6.0
In Commercial Distribution

  • 00628011382160 ()


  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.5.0
In Commercial Distribution

  • 00628011382153 ()


  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.4.0
In Commercial Distribution

  • 00628011382146 ()


  • Radiation therapy software
No Description
Siemens Healthcare GmbH
10830856
In Commercial Distribution

  • 04056869013077 ()


  • 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
No Description
Brainlab AG
3.0
In Commercial Distribution

  • 04056481142094 ()


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

  • 04056481140946 ()


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

  • 04056481140700 ()


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

  • 04056481140694 ()


  • Radiation therapy software
No Description
Brainlab AG
1.5
In Commercial Distribution

  • 04056481140403 ()


  • Radiation therapy software
No Description
Brainlab AG
1.5
Not in Commercial Distribution

  • 04056481140397 ()
21762-02A

  • Radiation therapy software
No Description
Brainlab AG
1.5
In Commercial Distribution

  • 04056481140380 ()


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

21381E

  • Radiation therapy software
No Description
Brainlab AG
5.0
Not in Commercial Distribution

  • 04056481131500 ()
21762-02

  • Radiation therapy software
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481007119 ()
21702-04C

  • Radiation therapy software
No Description
Brainlab AG
1.5
Not in Commercial Distribution

  • 04056481006853 ()
21702-04C

  • Radiation therapy software
No Description
Brainlab AG
1
Not in Commercial Distribution

  • 04056481000752 ()
21708

  • Radiation therapy software
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481000684 ()
20140-01

  • Radiation therapy software
No Description
Brainlab AG
4.1
In Commercial Distribution

  • 04056481000639 ()
21211F

  • Radiation therapy software
No Description
Brainlab AG
4.5
Not in Commercial Distribution

  • 04056481000592 ()
21381E

  • Radiation therapy software
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481000585 ()
21701-02

  • Radiation therapy software
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481000578 ()
21702-04B

  • Radiation therapy software
No Description
Brainlab AG
1.0
In Commercial Distribution

  • 04056481000561 ()
21703-02B

  • Radiation therapy software
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481000554 ()
21743-02

  • Radiation therapy software
No Description
Brainlab AG
1.0
Not in Commercial Distribution

  • 04056481000547 ()
21748-02

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

  • 04056481000530 ()


  • Radiation therapy software
No Description
Brainlab AG
1.5
In Commercial Distribution

  • 04056481000301 ()
32551C

  • Radiation therapy software
No Description
Eckert & Ziegler BEBIG GmbH
1374-0600#03
Not in Commercial Distribution

  • 04049223132088 ()
1374-0600

  • Radiation therapy software
No Description
Eckert & Ziegler BEBIG GmbH
1374-0600#01
Not in Commercial Distribution

  • 04049223118211 ()
1374-0600

  • Radiation therapy software
No Description
Eckert & Ziegler BEBIG GmbH
1374-0610#01
Not in Commercial Distribution

  • 04049223106751 ()
1374-0600

  • 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
VARIAN MEDICAL SYSTEMS, INC.
3.1
In Commercial Distribution

  • 00899475002608 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
2.2
In Commercial Distribution

  • 00899475002462 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00899475002431 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002424 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002417 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002400 ()


  • Radiation therapy software
The MOZI Treatment Planning System (MOZI TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. MOZI TPS is used to plan external beam irradiation with photon beams.
Manteia Technologies Co.,Ltd.
1.3
In Commercial Distribution

  • 06973127400067 ()


  • Radiation therapy software
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