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FDA 510(k) Applications Submitted by iCAD, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211506
05/14/2021
PowerLook Density Assessment V4.0
iCAD, Inc.
K141343
05/21/2014
AXXENT CERVICAL APPLICATOR
ICAD, INC.
K090223
01/30/2009
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
ICAD, INC.
K091529
05/22/2009
ICAD VERALOOK CTC CAD SOFTWARE
ICAD, INC.
K122951
09/25/2012
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
ICAD, INC.
K123442
11/08/2012
XOFT AXXENT CERVICAL APPLICATORS
ICAD, INC.
K121517
05/22/2012
VERSAVUE ENTERPRISE SUITE
ICAD, INC.
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