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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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GEAR VIEW QC CD
HYLAND LLC
2
In Commercial Distribution

  • 00850677007105 ()


  • Radiological PACS software
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software
3D Scanning and Digitizing Application for Electron Therapy Apertures
DECIMAL, INC.
N/A
In Commercial Distribution

  • 00851147007113 ()


  • Radiation therapy software
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
p.d software aid's radiation therapy professionals in the design, construction, and testing of radiotherapy beam modifying devices.
DECIMAL, INC.
5.1
In Commercial Distribution

  • 00851147007069 ()


  • Radiation therapy software
The HeartFlow Analysis is AI-based medical device software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries in the risk stratification and evaluation of coronary artery disease. The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution

  • 00853341006060 ()


  • Vascular modelling software
CORVUS 15 is intended for use as a planning tool for conformal radiation therapy. The CORVUS system is intended to be used as an integrated system with a delivery device for planning and delivery of conformal radiation therapy. . For IMRT, using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. For Forward Planning, CORVUS helps the user manually create a plan for treatment delivery based on user supplied inputs and patient scans including dose calculation. Forward Planning is supported only for Cobalt-60 based treatment planning.
Best Nomos
210764
In Commercial Distribution

  • 00852656007502 ()


  • Radiation therapy software
CORVUS 14 is intended for use as a planning tool for conformal radiation therapy. The CORVUS system is intended to be used as an integrated system with a delivery device for planning and delivery of conformal radiation therapy. . For IMRT, using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. For Forward Planning, CORVUS helps the user manually create a plan for treatment delivery based on user supplied inputs and patient scans including dose calculation. Forward Planning is supported only for Cobalt-60 based treatment planning.
Best Nomos
210735
In Commercial Distribution

  • 00852656007496 ()


  • Radiation therapy software
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
Best Nomos
210295
In Commercial Distribution

  • 00852656007427 ()


  • Radiation therapy software
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
Best Nomos
210296
In Commercial Distribution

  • 00852656007410 ()


  • Radiation therapy software
The Best TPS system is a computer based software system developed the use of assisting in the placement of anatomical localization and low dose rate isotope implants Best TPS uses multiple two-dimensional images including ultrasound and DICOM images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices.
Best Nomos
209867
In Commercial Distribution

  • 00852656007052 ()


  • Radiation therapy software
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
Best Nomos
210293
In Commercial Distribution

  • 00852656007045 ()


  • Radiation therapy software
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
Best Nomos
210294
In Commercial Distribution

  • 00852656007038 ()


  • Radiation therapy software
No Description
Disior Oy
Bonelogic 2.2
In Commercial Distribution

  • 06429810209221 ()


  • CAD/CAM software
No Description
Disior Oy
Bonelogic 2
In Commercial Distribution

  • 06429810209023 ()


  • CAD/CAM software
Littmann® Stethassist Heart And Lung Sound Visualization Software
3M COMPANY
ES1000
In Commercial Distribution

  • 00707387779054 ()
ES1000

  • Stethoscope application software
The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients. mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate. mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)). mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications.
Mint Medical GmbH
3.3.0
In Commercial Distribution

  • 14260495880331 ()


  • Radiological PACS software
ClearRead CT
Riverain Technologies, Inc.
3.6.1
In Commercial Distribution

  • M722C20338V203370 ()


  • Radiological PACS software
ClearRead +Compare on Connect Platform
Riverain Technologies, Inc.
3.3.1
In Commercial Distribution

  • M722C19129T190710 ()


  • Radiological PACS software
ClearRead Enhanced on Connect Platform
Riverain Technologies, Inc.
2.2.1
In Commercial Distribution

  • M722C19129E190710 ()


  • Radiological PACS software
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