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7 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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iCAD, Inc.
Authorized purpose: Concurrent CAD/CADx aid for interpreting physicians reading compatible DBT exams to detect soft-tissue densities and calcifications for physician confirmation or dismissal.
iCAD, Inc.
Authorized purpose: Provide a breast-density category from synthetic 2D images generated from DBT to aid assessment of breast tissue composition; the output is adjunctive and not a diagnostic aid.
iCAD Inc.
Authorized purpose: Concurrent or secondary CAD assistance to interpreting physicians for detection, localization, and characterization of soft-tissue densities (masses, architectural distortions, and asymmetries) and calcifications; not a primary read.
iCAD Inc.
Authorized purpose: Concurrent CAD for digital breast tomosynthesis interpretation.
iCAD Inc.
Authorized purpose: Concurrent CAD for interpreting physicians reading digital breast tomosynthesis examinations.
iCAD Inc
Concurrent computer-aided detection for radiologists interpreting compatible GE Senoclaire breast tomosynthesis examinations, with detected soft-tissue densities blended into the synthetic two-dimensional mammography image.
ICAD, INC.
Authorized purpose: The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has been completed, bringing them to the radiologist's attention and helping minimize observational oversights by identifying areas that may warrant a second review.