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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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No Description
INFINITT Healthcare Co.,Ltd.
INFINITT Cardiology PACS
In Commercial Distribution

  • 08809278790062 ()


  • Radiological PACS software
No Description
INFINITT Healthcare Co.,Ltd.
INFINITT PACS
In Commercial Distribution

  • 08809278790055 ()


  • Radiological PACS software
No Description
INFINITT Healthcare Co.,Ltd.
Reformat Gateway
In Commercial Distribution

  • 08809278790048 ()


  • Radiological PACS software
No Description
INFINITT Healthcare Co.,Ltd.
STARPACS Dental
In Commercial Distribution

  • 08809278790031 ()


  • Radiological PACS software
No Description
INFINITT Healthcare Co.,Ltd.
RapidiaColon System
In Commercial Distribution

  • 08809278790024 ()


  • Radiological PACS software
No Description
INFINITT Healthcare Co.,Ltd.
STARPACS Orthopedics System
In Commercial Distribution

  • 08809278790017 ()


  • Radiological PACS software
No Description
INFINITT Healthcare Co.,Ltd.
STARPACS
In Commercial Distribution

  • 08809278790000 ()


  • Radiological PACS software
No Description
Aural Analytics, Inc.
SDK
Not in Commercial Distribution

  • 00196852685837 ()


  • Cognitive assessment software
QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration.
Digiray Corp.
1.2.1.466
In Commercial Distribution

  • 08809466041112 ()


  • Radiological PACS software
ViewPoint 6 v6.15
GE Healthcare GmbH
6. ver15
In Commercial Distribution

  • 00195278753472 ()
H47601AA

  • Radiological PACS software
No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.3
In Commercial Distribution

  • 00842000100706 ()


  • Radiological PACS software
No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.2
In Commercial Distribution

  • 00842000100676 ()


  • Radiological PACS software
No Description
MERGE HEALTHCARE SOLUTIONS INC.
4.2.1
Not in Commercial Distribution

  • 00842000100652 ()


  • Radiological PACS software
No Description
MERGE HEALTHCARE SOLUTIONS INC.
11.0
In Commercial Distribution

  • 00842000100461 ()


  • Radiological PACS software
No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.1.2.1
In Commercial Distribution

  • 00842000100478 ()


  • Radiological PACS software
No Description
MERGE HEALTHCARE SOLUTIONS INC.
7.1.2.1
In Commercial Distribution

  • 00842000100454 ()


  • Radiological PACS software
No Description
MERGE HEALTHCARE SOLUTIONS INC.
4.2.1
Not in Commercial Distribution

  • 00842000100300 ()


  • Radiological PACS software
No Description
MERGE HEALTHCARE SOLUTIONS INC.
11.6.1
Not in Commercial Distribution

  • 00842000100140 ()


  • Radiological PACS software
Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.
MERGE HEALTHCARE SOLUTIONS INC.
1.0
In Commercial Distribution

  • 00842000100133 ()


  • Radiological PACS 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
HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self- administered but must be prescribed and must have results evaluated by a licensed medical professional. Moreover, HiPAL Pro must be initiated and supervised by professionals experienced in the use of cognitive assessment tools. The output score is aimed at screening for as well as aiding diagnosis and monitoring of Alzheimer’s disease (AD) and Cognitive Impairment. Scores are reviewed and interpreted by a licensed medical professional through an accompanying web portal.
GT DIAGNOSTICS (UK) LIMITED
1.0.1
In Commercial Distribution

  • G527GTDHIPALPRO01V1010 ()
GTD-HiPALPro-01

  • Cognitive assessment 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
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET,SPECT, Ultrasound &Mammography) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation,2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and CT colonoscopy.
SHINA SYSTEMS LTD.
3.2
In Commercial Distribution

  • 07290018235003 ()


  • Radiological PACS software
DTX Studio Lab 1.12 for Windows 64-bit
Nobel Biocare AB
1.12
In Commercial Distribution

  • 07332747180756 ()
300607

  • CAD/CAM software
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