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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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Viz CTP - 00811852030103

Viz CTP 1.3
VIZ.AI, INC.
1.3
Not in Commercial Distribution



  • Radiology DICOM image processing application software

Viz CTP - 00811852030066

Viz CTP 1.2
VIZ.AI, INC.
1.2
Not in Commercial Distribution



  • Radiology DICOM image processing application software

Viz CTP - 00811852030011

Viz CTP 1.1
VIZ.AI, INC.
1.1
Not in Commercial Distribution

  • 00811852030011 ()


  • Radiology DICOM image processing application software

OptiVu™ Mixed Reality - 00887868554490

No Description
Orthosoft Inc
OVMR-SW-2-0006
In Commercial Distribution

  • 00887868554490 ()

  • v.1.1
OVMR-SW-2-0006

  • Radiology DICOM image processing application software

OptiVu™ Mixed Reality - 00887868554483

No Description
Orthosoft Inc
OVMR-SW-2-0005
In Commercial Distribution

  • 00887868554483 ()

  • v.1.1
OVMR-SW-2-0005

  • Radiology DICOM image processing application software

AQAPS - AQAPS04

AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.
Terarecon Inc.
AQAPS04
In Commercial Distribution

  • AQAPS04 ()
AQAPS

  • Radiology DICOM image processing application software

Efficient Care 3D Planning - 00887868397547

No Description
Orthosoft Inc
302.4014
In Commercial Distribution

  • 00887868397547 ()
302.4014

  • Radiology DICOM image processing application software

Eureka - B2208430011

Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Terarecon Inc.
Eureka AI Results Explorer
In Commercial Distribution

  • B2208430011 ()


  • Radiology DICOM image processing application software

Ziostation - B131ZIOE1001SYS0P

A self-standing software program that adds specific image processing and/or analysis capabilities to radiological DICOM image data.
QI IMAGING LLC
2.4.3.1
In Commercial Distribution

  • B131ZIOE1001SYS0P ()
ZIOE1001SYS

  • Radiology DICOM image processing application software

M-Vu Algorithm Engine - M994MVU10500

The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device intended to aid radiologists in reading mammograms. It is a proprietary software application designed to process digitized film mammograms and digital mammograms. The mammogram images are automatically analyzed to mark areas for review by a radiologist. Results are displayed on either a mammography workstation, high resolution monitor, or printed case report.
VUCOMP, INC.
1050
In Commercial Distribution

  • M994MVU10500 ()


  • Radiology DICOM image processing application software
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