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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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BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.3.x.y
In Commercial Distribution

  • 07290018052235 ()


  • Radiology DICOM image processing application software
POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18059015375848 ()
TLHEXMODULESW1.1

  • Radiological PACS software
PREOPERATIVE JPS MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18053340345682 ()
JPSMODULESW

  • Radiological PACS software
Visix software for use with just an intraoral camera version 2.3.10
TELEVERE SYSTEMS, LLC
for Intraoral Camera 2.3.10
In Commercial Distribution

  • 00851800007092 ()
Visix for Intraoral Camera 2.3.10

  • Camera application software
  • Radiological PACS software
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.3
In Commercial Distribution

  • 00856104006123 ()


  • Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.2
In Commercial Distribution

  • 00856104006079 ()


  • Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.1
In Commercial Distribution

  • 00856104006024 ()


  • Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
1.1
In Commercial Distribution

  • 00856104006017 ()


  • Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
13.0
In Commercial Distribution

  • 00856104006000 ()


  • Radiation therapy treatment record/verify system
software versions 3.6.0, 3.7.0, 3.7.1, 3.8.0, 3.9.0 Annalise Triage (Annalise Critical Care AI) is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.6.0+
In Commercial Distribution

  • G140ANNALISEENTP50 ()
AnnaliseENTP5

  • X-ray image interpretive software
Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.4.1
In Commercial Distribution

  • G140ANNALISEENTP40 ()


  • Radiology DICOM image processing application software
Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.3.0
In Commercial Distribution

  • G140ANNALISEENTP30 ()


  • Radiology DICOM image processing application software
Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.2.0
In Commercial Distribution

  • G140ANNALISEENTP20 ()


  • Radiology DICOM image processing application software
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
MOBERG RESEARCH INC
VIS-100
In Commercial Distribution

  • B485VIS100 ()


  • Bioelectrical signal analysis software
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
NATUS NEUROLOGY INCORPORATED
1.03.00
In Commercial Distribution

  • B485CNSENV1000 ()


  • Bioelectrical signal analysis software
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
23.y.z
In Commercial Distribution

  • 07290018052297 ()


  • Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
22.y.z
In Commercial Distribution

  • 07290018052273 ()


  • Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
21.x.y
In Commercial Distribution

  • 07290018052259 ()


  • Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
19.x.y
In Commercial Distribution

  • 07290018052211 ()


  • Radiology DICOM image processing application software
CXR software versions 2.4.X+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
CXR - 2.4+
In Commercial Distribution

  • G140ANNALISECONTAINER60 ()
Annalisecontainer6

  • X-ray image interpretive software
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