(112 days)
syngo BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used.
syngo BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps).
Furthermore, it performs other user-defined post-processing functions such as image subtractions, multiplanar reformats and maximum intensity projections.
The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. syngo BreVis can also be used to provide measurements of the diameters, areas and volumes.
Furthermore syngo BreVis can evaluate the uptake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents.
syngo BreVis includes software to support the use of interventional coils and MR stereotactic localization devices to perform MR-quided interventional procedures (syngo BreVis Biopsy). Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, syngo BreVis provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.
syngo BreVis is optimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images. The images by other imaging modalities displayed with syngo BreVis must not be used for primary diagnostic interpretation.
syngo BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging and Data System).
When interpreted by a skilled physician, syngo BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo BreVis analysis.
syngo BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used.
syngo BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps).
Furthermore, it performs other user-defined post-processing functions such as image subtractions; multiplanar reformats and maximum intensity projections.
The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. syngo BreVis can also be used to provide measurements of the diameters, areas and volumes.
Furthermore syngo BreVis can evaluate the uptake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents.
syngo BreVis includes software to support the use of interventional coils and MR stereotactic localization devices to perform MR-guided interventional procedures (syngo BreVis Biopsy). Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, syngo BreVis provides an-automatic-calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.
syngo BreVis is optimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images. The images by other imaging modalities displayed with syngo BreVis must not be used for primary diagnostic interpretation.
syngo BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging and Data System).
When interpreted by a skilled physician, syngo BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo BreVis analysis.
The provided text describes the intended use and regulatory information for syngo BreVis, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot populate the requested information. The document focuses on regulatory clearance, device description, and equivalence to predicate devices, without detailing performance metrics or a validation study.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.