ICAD INC.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• icadmed.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• PowerLook® Tomo Detection Software

  2017-03-24

  ICAD Inc

• M-VU ALGORITHM ENGINE

  2017-01-11

  ICAD, INC.

• M-VU ALGORITHM ENGINE

  2015-03-02

  ICAD, INC.

• M-VU ALGORITHM ENGINE

  2014-06-06

  ICAD, INC.

• M-VU ALGORITHM ENGINE

  2013-12-02

  ICAD, INC.

• M-VU ALGORITHM ENGINE

  2013-06-19

  ICAD, INC.

• SECONDLOOK DIGITAL

  2013-06-19

  ICAD, INC.

• SECONDLOOK DIGITAL V7.2 CAD

  2012-11-09

  ICAD, INC.

• M-VU ALGOIRITHM ENGINE

  2012-10-01

  ICAD, INC.

• M-VU ALGORITHM ENGINE

  2012-01-23

  ICAD, INC.

• SECONDLOOK (SL) CAD

  2010-12-07

  ICAD, INC.

• SECONDLOOK (SL) CAD

  2008-10-09

  ICAD, INC.

• SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM

  2008-04-04

  ICAD, INC.

• SECONDLOOK

  2007-07-27

  ICAD, INC.

• SECOND LOOK

  2006-01-13

  ICAD, INC.

• SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

  2005-03-07

  ICAD, INC.

• SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

  2004-09-01

  ICAD, INC.

• ICAD SYSTEM

  2004-05-21

  ICAD, INC.

• ICAD SYSTEM

  2004-05-19

  ICAD, INC.

• ICAD SYSTEM

  2003-10-31

  ICAD, INC.

• ICAD SYSTEM

  2003-10-10

  ICAD, INC.

• ICAD

  2003-03-06

  ICAD, INC.

• ICAD

  2003-02-24

  ICAD, INC.

• ICAD

  2002-11-20

  ICAD, INC.

• SECOND LOOK

  2002-01-15

  ICAD, INC.

PMN#

• ProFound Detection (V4.0)

  2024-11-08

  Icad, Inc.

• PowerLook Density Assessment V4.0

  2021-07-12

  Icad, Inc.

• ProFound AI Software V3.0

  2021-03-12

  ICAD Inc.

• ProFound AI Software V2.1

  2019-10-04

  ICAD Inc.

• PowerLook Tomo Detection V2 Software

  2018-12-06

  ICAD Inc.

• PowerLook Density Assessment Software

  2018-04-05

  ICAD, Inc

• Axxent Electronic Brachytherapy System Model 110 XP 1200

  2016-02-25

  ICAD INC.

• AXXENT CERVICAL APPLICATOR

  2014-09-05

  ICAD, INC.

• XOFT AXXENT CERVICAL APPLICATORS

  2013-02-27

  ICAD, INC.

• XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110

  2013-01-17

  ICAD, INC.

• VERSAVUE ENTERPRISE SUITE

  2012-07-20

  ICAD, INC.

• ICAD VERALOOK CTC CAD SOFTWARE

  2010-08-04

  ICAD, INC.

• ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024

  2009-03-31

  ICAD, INC.

• SECOND LOOK VIEWER

  2004-11-19

  ICAD INC.

GUDID#

• PowerLook Tomo Detection (ProFound AI) - V2

  Icad, Inc.

  2018-12-27

• PowerLook Density Assessment V3.4 - "PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid.

  Icad, Inc.

  2018-07-06

• PowerLook PRO with Tomo Detection - The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.

  Icad, Inc.

  2017-04-03

• Powerlook PRO with SLD, FRU - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2017-04-03

• Powerlook PRO with SLD, GE, US - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2017-04-03

• PowerLook to PowerLook PRO Upgrade, US - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2017-04-03

• Powerlook PRO Hardware Upgrade, SLD - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2017-04-03

• DynaCAD - The DynaCAD 3 software consists of the MR Analysis Server software and the viewer workstation software. The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD Advanced PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images. The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. DynaCAD 3 software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD 3 software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist‘s existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.

  Icad, Inc.

  2016-11-18

• DynaLOC Breast Interventional Planning Software - The DynaLOC Breast Interventional Planning software module supports the use of MR interventional breast coils and localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device. The accuracy of DynaLOC software depends on the resolution of the acquired dataset. If the sum of the slice thicknesses for marker and target series does not exceed 5 mm, the 3-dimensional accuracy is 5 mm. Otherwise it is equal to the sum of two slice thicknesses for marker and target series. The accuracy can be negatively affected by any of the following: • Significant patient movement after the breast is securely immobilized in the biopsy device • Significant displacement of tissue during needle penetration • Image distortion in the MR dataset.

  Icad, Inc.

  2016-11-18

• PowerLook Tomo Detection and SecondLook Digital License - The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.

  Icad, Inc.

  2017-04-03

• iReveal with PowerLook AMP - PowerLook Density Assessment software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.

  Icad, Inc.

  2016-10-07

• PowerLook AMP PRO with SecondLook Digital - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2016-09-20

• PowerLook PRO Tomo Detection FRU - The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.

  Icad, Inc.

  2017-04-03

• PowerLook PRO with Tomo Detection, Upgrade, GE - The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.

  Icad, Inc.

  2017-04-03

• PowerLook PRO Tomo Detection and SLD, GE - The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.

  Icad, Inc.

  2017-04-03

• PowerLook Tomo Detection Software - The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.

  Icad, Inc.

  2017-04-03

• iReveal Breast Density Assessment - PowerLook Density Assessment is a software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.

  Icad, Inc.

  2016-09-23

• PowerLook AMP SLD FRU GE - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. Field Replacement System

  Icad, Inc.

  2014-09-22

• PowerLook AMP SLD FRU - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only. Field Replacement System

  Icad, Inc.

  2014-09-22

• PowerLook AMP SLD Philips - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2014-09-22

• PowerLook AMP SLD Hologic - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2014-09-22

• PowerLook AMP SLD Fuji - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2014-09-22

• PowerLook AMP SLD Siemens - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2014-09-22

• PowerLook AMP SLD GE Direct - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2014-09-22

• PowerLook AMP SLD GE US - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2014-09-22

• SecondLook Digital (SLD) - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2014-09-22

• ProFound AI - 2.1

  Icad, Inc.

  2019-07-11

• PowerLook AMP PRO, SLD, GE, ROW - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2021-05-17

• PowerLook AMP PRO, SLD, GE, ROW - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2021-05-17

• Powerlook PRO Hardware Upgrade, SLD - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2021-05-17

• Powerlook PRO Hardware Upgrade, SLD - The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

  Icad, Inc.

  2021-05-17

• PowerLook PRO Tomo Detection and SLD, GE - The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.

  Icad, Inc.

  2021-05-17

• PowerLook PRO Tomo Detection and SLD, GE - The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation. The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.

  Icad, Inc.

  2021-05-17

• PowerLook AMP SLD Agfa CR - DSC010-09

  Icad, Inc.

  2021-05-17

• PowerLook AMP SLD Planmed - DSC010-08

  Icad, Inc.

  2021-05-17

• PowerLook AMP SLD Philips OUS - DSC010-07-EU

  Icad, Inc.

  2021-05-17

• PowerLook AMP SLD Giotto - DSC010-06

  Icad, Inc.

  2021-05-17

• PowerLook AMP SLD Hologic OUS - DSC010-05-EU

  Icad, Inc.

  2021-05-17

• PowerLook AMP SLD Fuji OUS - DSC010-04-EU

  Icad, Inc.

  2021-05-17

• PowerLook AMP SLD Siemens OUS - DSC010-03-EU

  Icad, Inc.

  2021-05-17

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