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iCAD, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
14
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1243-2015Class IIDynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2January 21, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K240417ProFound Detection (V4.0)November 8, 2024
K211506PowerLook Density Assessment V4.0July 12, 2021
K203822ProFound AI Software V3.0March 12, 2021
K191994ProFound AI Software V2.1October 4, 2019
K182373PowerLook Tomo Detection V2 SoftwareDecember 6, 2018
K180125PowerLook Density Assessment SoftwareApril 5, 2018
K153570Axxent Electronic Brachytherapy System Model 110 XP 1200February 25, 2016
K141343AXXENT CERVICAL APPLICATORSeptember 5, 2014
K123442XOFT AXXENT CERVICAL APPLICATORSFebruary 27, 2013
K122951XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110January 17, 2013
K121517VERSAVUE ENTERPRISE SUITEJuly 20, 2012
K091529ICAD VERALOOK CTC CAD SOFTWAREAugust 4, 2010
K090223ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024March 31, 2009
K042697SECOND LOOK VIEWERNovember 19, 2004