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510(k) Data Aggregation
K Number
K212565Device Name
CoverScan v1
Manufacturer
Date Cleared
2022-05-19
(279 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Perspectum Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data.
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).
These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients.
CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
Device Description
CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen.
Metrics produced by CoverScan can be used by licensed physicians in a clinical setting for the purposes of assessing multiple organs.
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K Number
K203280Device Name
Hepatica v1 (Hepatica v1.0.0)
Manufacturer
Date Cleared
2021-01-12
(67 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Perspectum Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health.
Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported.
Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.
Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.
Device Description
Hepatica v1 is a standalone software device that imports MR datasets encompassing the abdomen, including the liver. Visualisation and display of T1-weighted MR data which can be analysed, and quantitative metrics of tissue characteristics and liver volume are then reported. Datasets imported into Hepatica are DICOM 3.0 compliant and reported metrics are independent of the MRI equipment vendor. It allows for the 3D visualisation of the liver and quantification of metrics (cT1, PDFF and volumetry) from liver tissue and exportation of results and images to a deliverable report. Hepatica v1 supports semi-automatic liver segmentation of T1-weighted volumetric data. Liver segmentation in Hepatica v1 requires the placement of anatomical landmarks to define the outer contours of the liver and can be adjusted by the operator, where necessary. Where available, whole liver and segmental cT1 and PDFF quantitative metrics derived from the predicate device may be presented in the final report. Hepatica uses volumetric datasets to create 2D anatomical views from all supported scanners. Where available, cT1 and PDFF parametric maps are derived from the predicate device. Quantified metrics and images derived from the analysis of liver volume and tissue characteristics are collated into a report for evaluation and interpretation by a clinician.
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