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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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Centricity - 00840682145572

No Description
GE HEALTHCARE
CPACS 7.0
In Commercial Distribution

  • 00840682145572 ()


  • Radiological PACS software

Centricity - 00840682145558

No Description
GE HEALTHCARE
CPACS 7.0
In Commercial Distribution

  • 00840682145558 ()


  • Radiological PACS software

AMA Optics Digital Vision Test - G506DG010

A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc.
AMA Optics, Inc.
DiagnosticGame
In Commercial Distribution

  • G506DG010 ()
DG01

  • Vision self-testing software

QuantX - B80731

QuantX is a software program that is used to view and analyze patient breast images.
QLARITY IMAGING, LLC
Breast MRI SE
Not in Commercial Distribution

  • B80731 ()
3

  • Radiological PACS software

QuantX - B80721

The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution

  • B80721 ()
2

  • Radiological PACS software

QuantX - B80711

QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
QLARITY IMAGING, LLC
Breast MRI
In Commercial Distribution

  • B80711 ()
1

  • Radiological PACS software

Medit ClinicCAD - 08800026700203

SW version: 0.9.x
Medit Corp.
Medit ClinicCAD
In Commercial Distribution

  • 08800026700203 ()


  • CAD/CAM software

Medit Splints - 08800026700173

SW version: 1.1.x
Medit Corp.
Medit Splints
In Commercial Distribution

  • 08800026700173 ()


  • CAD/CAM software

Medit Design - 08800026700159

SW version: 2.1.X
Medit Corp.
Medit Design
In Commercial Distribution

  • 08800026700159 ()


  • CAD/CAM software

Medit Temporaries - 08800026700180

SW Version: 1.1.x
Medit Corp.
Medit Temporaries
In Commercial Distribution

  • 08800026700180 ()


  • CAD/CAM software
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