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FDA 510(k) Applications Submitted by Heather Reed
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211506
05/14/2021
PowerLook Density Assessment V4.0
iCAD, Inc.
K191994
07/26/2019
ProFound AI Software V2.1
iCAD Inc.
K203822
12/29/2020
ProFound AI Software V3.0
iCAD Inc.
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