Address:4 Townsend West, Suite 9,Nashua,NH,03063,US
Device Description : Packaged Cutout 25 mm, xFlex
Device Class : 1
Duns Number: 108870254
Premarket Exempt : Yes
Prescription Use : No
Device Description : Packaged Cutout 27 mm, xFlex
Device Class : 1
Duns Number: 108870254
Premarket Exempt : Yes
Prescription Use : No
Device Description : Packaged Cutout 30mm, xFlex
Device Class : 1
Duns Number: 108870254
Premarket Exempt : Yes
Prescription Use : No
Device Description : Packaged Cutout 33mm, xFlex
Device Class : 1
Duns Number: 108870254
Premarket Exempt : Yes
Prescription Use : No
Device Description : Packaged Cutout set,xFlex
Device Class : 1
Duns Number: 108870254
Premarket Exempt : Yes
Prescription Use : No
Device Description : The DynaLOC Breast Interventional Planning software module supports the use of M 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.
Device Class : 2
Duns Number: 108870254
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DynaCAD 3 software consists of the MR Analysis Server software and the viewe 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.
Device Class : 2
Duns Number: 108870254
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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.
Device Class : 2
Duns Number: 108870254
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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.
Device Class : 2
Duns Number: 108870254
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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.
Device Class : 2
Duns Number: 108870254
Premarket Exempt : No
Prescription Use : Yes