Medical Device Manufacturer · US , Beavercreek , OH

Icad, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2004

Recent clearances: ProFound Detection (V4.0), PowerLook Density Assessment V4.0, ProFound AI Software V3.0

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Icad, Inc. Radiology ✕

14 devices

1-12 of 14

Cleared Nov 08, 2024

ProFound Detection (V4.0)

Radiology · 269d

Cleared Jul 12, 2021

PowerLook Density Assessment V4.0

Radiology · 59d

Cleared Mar 12, 2021

ProFound AI Software V3.0

Radiology · 73d

Cleared Oct 04, 2019

ProFound AI Software V2.1

Radiology · 70d

Cleared Dec 06, 2018

PowerLook Tomo Detection V2 Software

Radiology · 97d

Cleared Apr 05, 2018

PowerLook Density Assessment Software

Radiology · 79d

Cleared Feb 25, 2016

Axxent Electronic Brachytherapy System Model 110 XP 1200

Radiology · 73d

Cleared Sep 05, 2014

AXXENT CERVICAL APPLICATOR

Radiology · 107d

Cleared Feb 27, 2013

XOFT AXXENT CERVICAL APPLICATORS

Radiology · 111d

Cleared Jan 17, 2013

XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110

Radiology · 114d

Cleared Jul 20, 2012

VERSAVUE ENTERPRISE SUITE

Radiology · 59d

Cleared Aug 04, 2010

ICAD VERALOOK CTC CAD SOFTWARE

Radiology · 439d