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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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VolparaDensity - 09421904268258

VolparaDensity 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution

  • 09421904268258 ()


  • Radiological PACS software

VolparaDensity - 09421904268241

No Description
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.0
In Commercial Distribution

  • 09421904268241 ()


  • Radiological PACS software

JiveX - 04260632470084

Version 5.4+ includes all minor versions and patch levels of 5.4 as well as higher versions (e.g. 5.5) in case no new 510(k) submission is needed.
VISUS Health IT GmbH
5.4+
In Commercial Distribution

  • 04260632470084 ()


  • Radiological PACS software

JiveX - 04260632470039

Version 5.3 includes all minor versions and patch levels of 5.3
VISUS Health IT GmbH
5.3
Not in Commercial Distribution

  • 04260632470039 ()


  • Radiological PACS software

JiveX - 04260632470022

Version 5.2 includes all minor versions and patch levels of 5.2
VISUS Health IT GmbH
5.2
Not in Commercial Distribution

  • 04260632470022 ()


  • Radiological PACS software

JiveX - 04260632470015

Version 5.1 includes all minor versions and patch levels of 5.1
VISUS Health IT GmbH
5.1
Not in Commercial Distribution

  • 04260632470015 ()


  • Radiological PACS software

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

Limbus Contour - 00628011382184

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 - 00628011382177

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 - 00628011382160

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 - 00628011382153

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 - 00628011382146

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

EBM - 04719878879996

No Description
EBM TECHNOLOGIES INCORPORATED
UniWeb 360
In Commercial Distribution

  • 04719878879996 ()


  • Radiological PACS software

EBM - 04719878879989

No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS" App 1.2.1, Rad@
In Commercial Distribution

  • 04719878879989 ()


  • Radiological PACS software

EBM - 04719878879972

No Description
EBM TECHNOLOGIES INCORPORATED
SoliPACS™ Web Viewer ,version 8.0
In Commercial Distribution

  • 04719878879972 ()


  • Radiological PACS software

EBM - 04719878879965

No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS™ App
In Commercial Distribution

  • 04719878879965 ()


  • Radiological PACS software

EBM - 04719878879958

No Description
EBM TECHNOLOGIES INCORPORATED
EBM VS 1000
In Commercial Distribution

  • 04719878879958 ()


  • Radiological PACS software

EBM - 04719878879941

No Description
EBM TECHNOLOGIES INCORPORATED
SoliPACS™ Client Viewer with SoliPACS™ Gateway
In Commercial Distribution

  • 04719878879941 ()


  • Radiological PACS software

EBM - 04719878879934

No Description
EBM TECHNOLOGIES INCORPORATED
SoliPACS™ Client Viewer, version 4.0
In Commercial Distribution

  • 04719878879934 ()


  • Radiological PACS software

EBM - 04719878879927

No Description
EBM TECHNOLOGIES INCORPORATED
SoliPACS™ Web Viewer ,version 5.0
In Commercial Distribution

  • 04719878879927 ()


  • Radiological PACS software

EBM - 04719878879910

No Description
EBM TECHNOLOGIES INCORPORATED
SoliPACS™ Server
In Commercial Distribution

  • 04719878879910 ()


  • Radiological PACS software

EasyCare Tx - 00619498259458

EasyCare Tx V9.0 CD ASSY
RESMED PTY LTD
25945
In Commercial Distribution

  • 00619498259458 ()
25945

  • Ventilator application software

EasyCare Tx - 00619498259441

EasyCare Tx CD ASSY
RESMED PTY LTD
25944
In Commercial Distribution

  • 00619498259441 ()
25944

  • Ventilator application software

RESSCAN - 00619498229154

RESSCAN DATA CARD MODULE
RESMED PTY LTD
22915
In Commercial Distribution

  • 00619498229154 ()
22915

  • Ventilator application software

AirMini app - 00619498222445

Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application software

AirMini app - 00619498222438

iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software

AIRVIEW - 00619498222407

AIRVIEW
RESMED PTY LTD
22240
In Commercial Distribution

  • 00619498222407 ()
22240

  • Ventilator application software

RESSCAN - 00619498222070

RESSCAN DATA CARD READER
RESMED PTY LTD
22207
In Commercial Distribution

  • 00619498222070 ()
22207

  • Ventilator application software

RESSCAN - 00619498222032

RESSCAN USB ADAPTER
RESMED PTY LTD
22203
In Commercial Distribution

  • 00619498222032 ()
22203

  • Ventilator application software

ResScan - 00619498313365

ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution

  • 00619498313365 ()
31336

  • Ventilator application software
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