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FDA 510(k) Applications Submitted by iCAD Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K191994
07/26/2019
ProFound AI Software V2.1
iCAD Inc.
K203822
12/29/2020
ProFound AI Software V3.0
iCAD Inc.
K182373
08/31/2018
PowerLook Tomo Detection V2 Software
iCAD Inc.
K153570
12/14/2015
Axxent Electronic Brachytherapy System Model 110 XP 1200
ICAD INC.
K042697
09/30/2004
SECOND LOOK VIEWER
ICAD INC.
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