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3 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Imbio, Inc.
Authorized purpose: Passive referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not diagnosis.
Imbio, Inc
The Imbio PHA Software device is designed to measure the maximal diameters of the right and left ventricles of the heart, the main pulmonary artery, and the ascending aorta from a volumetric CTPA acquisition and report the RV/LV and Pa/Ao ratios. PHA analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the anatomy. The PHA software provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.
Imbio, Inc.
Authorized purpose: Provides non-invasive post-processing to quantify possible coronary calcifications and output Agatston score, arterial age, mass, and volume.