M-VU ALGORITHM ENGINE
ICAD, INC.
iCAD, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1225671 | 3001451447 | iCAD, Inc. | 1 | N | 2020-04-25 | 4 Townsend West, Suite 9 Nashua NH US 03063 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 91532 | 1722851553 | P160009 | PowerLook® Tomo Detection Software | MYN | 2017-03-24 |
| 91532 | 1230689067 | P010038 | SECOND LOOK | MYN | 2002-01-15 |
| 91532 | 1556064553 | K970908 | HOWTEK 960 | LMA | 1997-05-20 |
| 91532 | 1274702012 | K191994 | ProFound AI Software V2.1 | QDQ | 2019-10-04 |
| 91532 | 1699911152 | K182373 | PowerLook Tomo Detection V2 Software | QDQ | 2018-12-06 |
| 91532 | 1548729328 | K180125 | PowerLook Density Assessment Software | LLZ | 2018-04-05 |
| 91532 | 1323716527 | K132742 | M-VU BREAST DENSITY | LLZ | 2013-12-03 |
| 91532 | 1469438794 | K091529 | ICAD VERALOOK CTC CAD SOFTWARE | JAK | 2010-08-04 |
| 91532 | 1228314567 |
Product Codes Associated With Registrations#
PMA#
M-VU ALGORITHM ENGINE
ICAD, INC.
M-VU ALGORITHM ENGINE
ICAD, INC.
M-VU ALGORITHM ENGINE
ICAD, INC.
M-VU ALGORITHM ENGINE
ICAD, INC.
SECONDLOOK DIGITAL
ICAD, INC.
SECONDLOOK DIGITAL V7.2 CAD
ICAD, INC.
M-VU ALGOIRITHM ENGINE
ICAD, INC.
M-VU ALGORITHM ENGINE
ICAD, INC.
SECONDLOOK (SL) CAD
ICAD, INC.
SECONDLOOK (SL) CAD
ICAD, INC.
SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
ICAD, INC.
SECONDLOOK
ICAD, INC.
SECOND LOOK
ICAD, INC.
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
ICAD, INC.
SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
ICAD, INC.
ICAD SYSTEM
ICAD, INC.
ICAD SYSTEM
ICAD, INC.
ICAD SYSTEM
ICAD, INC.
ICAD SYSTEM
ICAD, INC.
ICAD
ICAD, INC.
ICAD
ICAD, INC.
ICAD
ICAD, INC.
SECOND LOOK
ICAD, INC.
PMN#
ProFound Detection (V4.0)
Icad, Inc.
PowerLook Density Assessment V4.0
Icad, Inc.
AXXENT CERVICAL APPLICATOR
ICAD, INC.
XOFT AXXENT CERVICAL APPLICATORS
ICAD, INC.
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
ICAD, INC.
VERSAVUE ENTERPRISE SUITE
ICAD, INC.
ICAD VERALOOK CTC CAD SOFTWARE
ICAD, INC.
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
ICAD, INC.
GUDID#
ProFound AI V3.0 - 3.0
2021-05-17
PowerLook AMP with Density Assessment GE US - DSC012-02
2021-05-17
PowerLook AMP with Density Assessment GE OUS - DSC012-03
2021-05-17
PowerLook AMP SLD GE OUS - DSC010-01-EU
2021-05-17
PowerLook AMP SLD GE OUS Direct - DSC010-12-EU
2021-05-17
PowerLook AMP SLD Siemens OUS - DSC010-03-EU
2021-05-17
PowerLook AMP SLD Fuji OUS - DSC010-04-EU
2021-05-17
PowerLook AMP SLD Hologic OUS - DSC010-05-EU
2021-05-17
PowerLook AMP SLD Giotto - DSC010-06
2021-05-17
PowerLook AMP SLD Philips OUS - DSC010-07-EU
2021-05-17
PowerLook AMP SLD Planmed - DSC010-08
2021-05-17
PowerLook AMP SLD Agfa CR - DSC010-09
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.
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.
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.
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.
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.
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.
2021-05-17
ProFound AI - 2.1
2019-07-11
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.
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.
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.
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.
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.
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.
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.
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
2014-09-22
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
2014-09-22
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.
2016-09-23
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.
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.
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.
2017-04-03
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.
2017-04-03
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.
2016-09-20
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.
2016-10-07
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.
2017-04-03
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.
2016-11-18
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.
2016-11-18
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.
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.
2017-04-03