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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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OrthoNext™ Platform System Software - 18059015375848

POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18059015375848 ()
TLHEXMODULESW1.1

  • Radiological PACS software

OrthoNext™ Platform System Software - 18053340345682

PREOPERATIVE JPS MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18053340345682 ()
JPSMODULESW

  • Radiological PACS software

Visix - 00851800007092

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

Varian Verification Console - 00856104006123

No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.3
In Commercial Distribution

  • 00856104006123 ()


  • Radiation therapy treatment record/verify system

Varian Verification Console - 00856104006079

No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.2
In Commercial Distribution

  • 00856104006079 ()


  • Radiation therapy treatment record/verify system

Verification Console - 00856104006024

No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.1
In Commercial Distribution

  • 00856104006024 ()


  • Radiation therapy treatment record/verify system

Varian Verification System (VVS) - 00856104006017

No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
1.1
In Commercial Distribution

  • 00856104006017 ()


  • Radiation therapy treatment record/verify system

Varian Treatment - 00856104006000

No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
13.0
In Commercial Distribution

  • 00856104006000 ()


  • Radiation therapy treatment record/verify system

Annalise Triage - G140ANNALISEENTP50

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 - G140ANNALISEENTP40

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
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