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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 - 07290018052235

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

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

Annalise Enterprise - G140ANNALISEENTP30

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 - G140ANNALISEENTP20

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

CNS Envision - B485VIS100

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

CNS Envision - B485CNSENV1000

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 Triage - 07290018052297

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 Triage - 07290018052273

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 Triage - 07290018052259

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 Triage - 07290018052211

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

Annalise Critical Care AI - G140ANNALISECONTAINER60

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

DIERS postura - 04260242060194

No Description
DIERS International GmbH
n/a
In Commercial Distribution

  • 04260242060194 ()


  • Radiological video camera patient positioning/tracking system

DIERS statico - 04260242060101

No Description
DIERS International GmbH
II
In Commercial Distribution

  • 04260242060101 ()


  • Radiological video camera patient positioning/tracking system

DIERS formetric - 04260242060019

No Description
DIERS International GmbH
III 4D
In Commercial Distribution

  • 04260242060019 ()


  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372680

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
In Commercial Distribution

  • 04260590372680 ()
0018365-0001

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372673

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372673 ()
0018440

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372666

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372666 ()
0018438

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372659

No Description
L A P GMBH LASER APPLIKATIONEN
Central Server host PC Luna 3D
In Commercial Distribution

  • 04260590372659 ()
0018439-0001

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372642

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372642 ()
0018346-0003

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372635

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372635 ()
0018346-0002

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372628

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372628 ()
0018440

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372611

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372611 ()
0018438

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372604

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
Not in Commercial Distribution

  • 04260590372604 ()
0018914

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372598

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372598 ()
0018364-0009

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372581

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372581 ()
0018364-0008

  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500597

SimRT version 7.2
VISION RT LIMITED
SimRT 7.2
In Commercial Distribution

  • 05056190500597 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500580

SimRT system, version 7.2
VISION RT LIMITED
SimRT 7.2 system
In Commercial Distribution

  • 05056190500580 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500566

No Description
VISION RT LIMITED
Lenovo P340 workstation
In Commercial Distribution

  • 05056190500566 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500559

No Description
VISION RT LIMITED
AlignRT InBore 6.4
In Commercial Distribution

  • 05056190500559 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500542

No Description
VISION RT LIMITED
InBore Power Repeater
In Commercial Distribution

  • 05056190500542 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500535

No Description
VISION RT LIMITED
InBore System Cabinet
In Commercial Distribution

  • 05056190500535 ()


  • Radiological video camera patient positioning/tracking system
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