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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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iReveal Breast Density Assessment - 00858012005205

PowerLook Density Assessment is a software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.
Icad, Inc.
V2.1
In Commercial Distribution

  • 00858012005205 ()
D70124, D70141 and D70126

  • Basic diagnostic x-ray system application software

PowerLook AMP SLD Agfa CR - 00858012005175

No Description
Icad, Inc.
DSC010-09
In Commercial Distribution

  • 00858012005175 ()


  • Basic diagnostic x-ray system application software

PowerLook AMP SLD Planmed - 00858012005168

No Description
Icad, Inc.
DSC010-08
In Commercial Distribution

  • 00858012005168 ()


  • Basic diagnostic x-ray system application software

PowerLook AMP SLD Philips OUS - 00858012005151

No Description
Icad, Inc.
DSC010-07-EU
In Commercial Distribution

  • 00858012005151 ()


  • Basic diagnostic x-ray system application software

PowerLook AMP SLD Giotto - 00858012005144

No Description
Icad, Inc.
DSC010-06
In Commercial Distribution

  • 00858012005144 ()


  • Basic diagnostic x-ray system application software

PowerLook AMP SLD Hologic OUS - 00858012005137

No Description
Icad, Inc.
DSC010-05-EU
In Commercial Distribution

  • 00858012005137 ()


  • Basic diagnostic x-ray system application software

PowerLook AMP SLD Fuji OUS - 00858012005120

No Description
Icad, Inc.
DSC010-04-EU
In Commercial Distribution

  • 00858012005120 ()


  • Basic diagnostic x-ray system application software

PowerLook AMP SLD Siemens OUS - 00858012005113

No Description
Icad, Inc.
DSC010-03-EU
In Commercial Distribution

  • 00858012005113 ()


  • Basic diagnostic x-ray system application software

PowerLook AMP SLD GE OUS Direct - 00858012005106

No Description
Icad, Inc.
DSC010-12-EU
In Commercial Distribution

  • 00858012005106 ()


  • Basic diagnostic x-ray system application software

PowerLook AMP SLD GE OUS - 00858012005090

No Description
Icad, Inc.
DSC010-01-EU
In Commercial Distribution

  • 00858012005090 ()


  • Basic diagnostic x-ray system application software
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