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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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The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution

  • 00858012005212 ()
DS0244, D70130

  • Basic diagnostic x-ray system application software
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
No Description
Icad, Inc.
DSC010-09
In Commercial Distribution

  • 00858012005175 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-08
In Commercial Distribution

  • 00858012005168 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-07-EU
In Commercial Distribution

  • 00858012005151 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-06
In Commercial Distribution

  • 00858012005144 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-05-EU
In Commercial Distribution

  • 00858012005137 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-04-EU
In Commercial Distribution

  • 00858012005120 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-03-EU
In Commercial Distribution

  • 00858012005113 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-12-EU
In Commercial Distribution

  • 00858012005106 ()


  • Basic diagnostic x-ray system application software
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