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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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No Description
Hologic, Inc.
I-View 2.0 Software
In Commercial Distribution

  • 15420045512665 ()
SW-05943

  • Stationary mammographic x-ray system, digital
Intelligent 2D™ is a software feature where a high-resolution digital mammography image is generated from data acquired during a high-resolution breast tomosynthesis scan. The high resolution tomosynthesis image and the Intelligent 2D image have a pixel resolution of 70 microns.
Hologic, Inc.
INTELLIGENT 2D SOFTWARE
In Commercial Distribution

  • 15420045507289 ()
SW-04882

  • Stationary mammographic x-ray system, digital
Hologic Clarity HD® (high resolution tomosynthesis) is a software driven digital breast tomosynthesis 3(D) imaging feature intended to improve image resolution on tomosynhesis slices and synthesized 2D images that will enhance image quality and user experience.
Hologic, Inc.
CLARITY HD SOFTWARE
In Commercial Distribution

  • 15420045507272 ()
SW-04756

  • Stationary mammographic x-ray system, digital
AFFIRM SYSTEM, S/W 3D LICENSE
Hologic, Inc.
3D System Software
In Commercial Distribution

  • 15420045504738 ()
SW-04300

  • Mammographic stereotactic biopsy system
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.17
In Commercial Distribution

  • 00854344007764 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.16
In Commercial Distribution

  • 00854344007757 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.15
In Commercial Distribution

  • 00854344007740 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.14
In Commercial Distribution

  • 00854344007733 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.13
In Commercial Distribution

  • 00854344007726 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.12
In Commercial Distribution

  • 00854344007696 ()


  • X-ray system computer, diagnostic, general-purpose
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