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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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ThinPrep Imaging System - 15420045508040

Automated cytology review microscope with ThinPrep® slide imaging functionality.
Hologic, Inc.
ThinPrep Imaging System Review Scope
In Commercial Distribution

  • 15420045508040 ()
ASY-07233

  • Laboratory instrument/analyser application software IVD

SecurView DX Manager - 15420045507388

The SecurView® DX diagnostic workstation Manager provides central database access and performs the image preparation for all connected SecurView DX Client workstations.
Hologic, Inc.
SVDX Manager
In Commercial Distribution

  • 15420045507388 ()
SVDX-00600-HIRES

  • Laboratory instrument/analyser application software IVD

SecurViewRT Manager - 15420045507371

The SecurView® RT technologist workstation Manager provides central database access and performs the image preparation for all connected SecurView RT Client workstations.
Hologic, Inc.
SVRT Manager
In Commercial Distribution

  • 15420045507371 ()
SVRT-00600R

  • Laboratory instrument/analyser application software IVD

SecurViewRT Mammorgraphy Workstation - 15420045507364

The SecurView® RT technologist workstation is intended to be used by technologists to view images durign screening and diagnostic exams.
Hologic, Inc.
SVRT
In Commercial Distribution

  • 15420045507364 ()
SVRT-00300

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507265

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507265 ()
ASY-10745

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507258

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507258 ()
CMP-01515

  • Laboratory instrument/analyser application software IVD

PRIMA - 15420045504691

Prima
Hologic, Inc.
PRIMA
Not in Commercial Distribution

  • 15420045504691 ()


  • Laboratory instrument/analyser application software IVD

MULTIVIEW - 15420045504684

MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis.
Hologic, Inc.
MultiView
In Commercial Distribution

  • 15420045504684 ()
SFW-03541

  • Laboratory instrument/analyser application software IVD

SecurView Diagnostic Workstation - 15420045504523

The SecurView® DX diagnostic workstation software is an application that displays images on mammography review workstations for use by radiologists in the interpretation of images acquired from mammography and digital breast tomosynthesis.
Hologic, Inc.
SecurView DX
In Commercial Distribution

  • 15420045504523 ()


  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504103

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504103 ()
ASY-08346

  • Laboratory instrument/analyser application software IVD
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